Medizintechnik GmbH Product Recall Bionic

Medizintechnik GmbH Product Recall Bionic

Medizintechnik GmbH
.... a JMS-corporation
ßionic Medizintechnik GmbH
Max-Planck-Straße 21
0-61381 Friedrichsdorf, Cermany
Phone: +49 (0) 61 72-7576-0
Fax:
+49 (0) 61 72-7576-10
E-mail: [email protected]
www.bionic-jms.com
Ust-IO Nr./VAT-No: OE 811 584315
St.-Nr./TIN: 003 22950287
Bionic Medizintechnik GmbH, Max-Planck-Straße 21, 0-61381 Friedrichsdorf
Product Recall Bionic PointGuard® anti stick fistula needle
To whom it may concern
We had been notified about an incident during dialysis treatment involving a Bionic anti stick needle
type "PointGuard". The incrirninated anti stick fistula needle in this reported case was apparently
retracted unintentionally into the protection sheath. The fistula needle dislocated resulting in a blood
loss.
The result of our failure analysis highlights the possibility of unintentional rotation of the fistula
needle due to patient movements, giving way to retract into the disposal position. A subsequent pull
at the blood tubing resulted in dislocation from the puncture site. Appropriate fixation of the tubing,
as recommended in the instruction for use, was not in place.
We had been notified by the "Bundesinstitut für Arzneimittel und Medizinprodukte", BfArM, the
German Medical Device Competent Authority, that they regard the risk deriving from the use
of Bionic PointGuard anti stick needles being not acceptable. For this reason we recall
precautionary all Bionic PointGuard anti stick needles and ask you to refrain from using the
products.
Please let us know who is our designated correspondent in your entity, being responsible for
handling this recall and wh ich PointGuard anti stick needles are in stock. We will contact you by
return for clearing. Our distributors are requested to contact product end users accordingly.
In case of questions, please do not hesitate to contact uso For sure we are at your disposal
at our Headquarters main line in Friedrichsdorf/Germany under +49 6172 7576-0 or mail us to
[email protected].
We apologize for the trouble caused by this product recall.
Sincerely yours,
Bionic Medizintechnik GmbH
Vbflv
Ralf Jungmann
President
Sitz der Cesellschaft/Commercial Register:
Bad Homburg HRB 5186
.
Geschf:ifts!lihrer/CE:.O: Raif Jungmann, Llmeshatr1;
Leo Allegra, Usingen; Yoshio Kondo, Hiroshirna
Dresdner Bank Frankfurt
KTO/Acc.-No:
0729064000
Bll/Bank Code: 500 800 00
IBAN EUR: DE25 5008 0000 0729 0640 00
SwiftlBIC: ORtS DE FE 523
Taunus-Sparkasse Bad Homburg
KTO/Acc.-No:
200220 35
Bll/Bank Code: 512 50000
IBAN EUR: DE63 5125 000000200220 35
SwiftiBIC: HElA OE FITSI<
IBAN USO: DE76 512500000096 0143 17
Bank of Tokyo-MiLsubishi UF) Oüsseldorf
511 205724
KTO/Acc.-No:
Bll/Bank Code: 300 107 00
IBAN: DE08 3001 07000000205724
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