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Adverse Event Report

B. BRAUN MEDICAL, INC. PENCAN SPINAL TRAY   back to search results
Model Number P27LK
Event Date 11/19/2002
Event Type  Injury   Patient Outcome  Required Intervention;
Manufacturer Narrative

The actual sample involved in the incident was returned for the mfr to evaluate. The sample had the needle separated from the hub. The hub appeared to have been properly crimped and there was sufficient frit blasting on the needle. The smaple was forwarded to the actual mfr, american medical instruments, inc. , for evaluation. Ami concluded that the cannula portion of the introducer that separated was not fully inserted into the hub when it was staked/crimped and may have been loosened by the manual pull test with a subsequent failure in the field. Ami has implemented corrective and preventive action to ensure this does not recur.

 
Event Description

Introducer needle broke off in patient. Needle recovered.

 
Manufacturer Narrative

The actual sample has not yet been received for evaluation. Without the sample, a thorough investigation of this incident cannot be performed and no specific conclusions can be drawn. No patient injury has occurred and the patient has suffered no adverse sequelae due to this incident. The needle was easily removed from under the skin immediately during the original procedure. If the sample is received by the manufacturer, a follow-up report will be filed.

 
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Brand NamePENCAN
Type of DeviceSPINAL TRAY
Baseline Brand NamePENCAN
Baseline Generic NameSPINAL TRAY
Baseline Catalogue Number333872
Baseline Model NumberP27LK
Baseline Device FamilyPENCIL POINT SPINAL TRAY
Baseline Device 510(K) NumberK932569
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)12
Date First Marketed01/26/1994
Manufacturer (Section F)
B. BRAUN MEDICAL, INC.
901 marcon blvd.
allentown PA 18103
Manufacturer (Section D)
B. BRAUN MEDICAL, INC.
901 marcon blvd.
allentown PA 18103
Manufacturer Contact
art morse
901 marcon blvd.
allentown , PA 18103
(610) 266 -0500
Device Event Key424219
MDR Report Key435283
Event Key411920
Report Number2523676-2002-00074
Device Sequence Number1
Product CodeHAS
Report Source Manufacturer
Source Type User facility
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/23/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date06/30/2004
Device MODEL NumberP27LK
Device Catalogue Number333872
Device LOT Number60373817
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/19/2002
Device Ageunknown
Event Location Hospital
Date Manufacturer Received11/27/2002
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on February 28, 2009

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