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Adverse Event Report

B BRAUN MEDICAL B BRAUN EPIDURAL ANESTHESIA TRAY   back to search results
Catalog Number CE18TK
Patient Outcome  Other;
Event Description

Plunger of 5 ml glass luer lock syringe stuck (did not slide freely) when pt was receiving epidural steroid injection. Pt developed a spinal headache. Md believes nerve root was touched with needle, when plunger became unstuck.

 
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Brand NameB BRAUN
Type of DeviceEPIDURAL ANESTHESIA TRAY
Baseline Brand NamePERIFIX
Baseline Generic NameCUSTOM EPIDURAL ANESTHESIA TRAY
Baseline Catalogue Number332220
Baseline Model NumberCE18TK
Baseline Device FamilyCUSTOM EPIDURAL ANESTHESIA TRAY
Baseline Device 510(K) NumberK840179
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)60
Date First Marketed02/24/1984
Manufacturer (Section D)
B BRAUN MEDICAL
901 marcon blvd
allentown PA 18103 9341
Device Event Key297832
MDR Report Key307833
Event Key289286
Report NumberMW1020542
Device Sequence Number1
Product CodeCAZ
Report Source Voluntary
Report Date 11/30/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/30/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCE18TK
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on January 30, 2009

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