* P2535 333853

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 2004-11-04 for * P2535 333853 manufactured by B. Braun Medical, Inc..

Event Text Entries

[20525615] A pt undergoing a cesarean section delivery elected to have spinal anesthesia. During the spinal procedure, the 25 ga pencan needle fractured at approximately half its overall length. The delivery was completed with no further complications. The decision was made to leave the fragment (4. 3cm) in the pt for later surgical extraction. X-ray and ct scans confirmed that the needle fragment was embedded in the posterior paraspinous soft tissue. The pt has been discharged and remedial surgery is pending. Add'l info received by the sales rep: sales rep called the account to see what happened, and spoke to the physician that experienced this incident. Firstly, a crna tried a few times to do the block. The pt was complaining of pain upon every attempt. Dr was called in to do the block. The doctor attempted 3-4 times, but kept hitting bone. He would pull back with the same needle, and re-direct the needle. He never pulled the stylet out, obviously got no csf return and decided to abandon the procedure with this needle. Upon withdrawal, he felt a "drag" and noticed about 40% of the needle remained in the pt's back. He then chose a different insertion location, as not to disturb the fragment of the needle, and used a 22 ga. Via a paramedian approach. He was successful with this block. The pt firstly decided against having the remnant removed, however, has since change their mind. Dr seems to think that all will work out in the end, especially for the pt. The pt has returned to the hospital with pain and is scheduled to have the needle fragment removed. Rep is in possession of the needle hub and will be in possession of the fractured portion of needle once it is removed from the pt, however, the sample will remain with the facility's risk management dept. And will not be released to b. Braun. Rep will notify b. Braun if there are any add'l adverse events related to the removal of the fractured needle.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523676-2004-00073
MDR Report Key553990
Report Source06
Date Received2004-11-04
Date of Report2004-10-26
Date of Event2004-09-07
Date Mfgr Received2004-10-04
Date Added to Maude2004-11-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactKIKOO TEJWANI
Manufacturer Street901 MARCON BLVD.
Manufacturer CityALLENTOWN PA 18109
Manufacturer CountryUS
Manufacturer Postal18109
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 Name*
Generic Name*
Product CodeHAS
Date Received2004-11-04
Model NumberP2535
Catalog Number333853
Lot NumberUNK
ID NumberNA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key543617
ManufacturerB. BRAUN MEDICAL, INC.
Manufacturer Address* ALLENTOWN PA 18109 US
Baseline Brand NamePENCAN
Baseline Generic NamePENCIL POINT SPINAL NEEDLE
Baseline Model NoP2535
Baseline Catalog No333853
Baseline IDNA
Baseline Device FamilyPENCIL POINT SPINAL NEEDLE
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]60
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK932569
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2004-11-04

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