PENCAN P27LK 333872

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-12-30 for PENCAN P27LK 333872 manufactured by B. Braun Medical, Inc..

Event Text Entries

[297912] Introducer needle broke off in patient. Needle recovered.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523676-2002-00074
MDR Report Key435283
Report Source06
Date Received2002-12-30
Date of Report2002-12-23
Date of Event2002-11-19
Date Facility Aware2002-11-19
Report Date2002-12-23
Date Mfgr Received2002-11-27
Date Added to Maude2003-01-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactART MORSE
Manufacturer Street901 MARCON BLVD.
Manufacturer CityALLENTOWN PA 18103
Manufacturer CountryUS
Manufacturer Postal18103
Manufacturer Phone6102660500
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Remedial ActionOT
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NamePENCAN
Generic NameSPINAL TRAY
Product CodeHAS
Date Received2002-12-30
Model NumberP27LK
Catalog Number333872
Lot Number60373817
ID NumberNA
Device Expiration Date2004-06-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeUNKNOWN
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key424219
ManufacturerB. BRAUN MEDICAL, INC.
Manufacturer Address901 MARCON BLVD. ALLENTOWN PA 18103 US
Baseline Brand NamePENCAN
Baseline Generic NameSPINAL TRAY
Baseline Model NoP27LK
Baseline Catalog No333872
Baseline IDNA
Baseline Device FamilyPENCIL POINT SPINAL TRAY
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]12
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK932569
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2002-12-30

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