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Adverse Event Report

BD MEDICAL SYSTEMS BD MED SYSTEMS SPINAL NEEDLE   back to search results
Catalog Number 405164
Device Problems Device breakage; Component(s), broken; Device, or device fragments remain in patient
Event Date 07/30/2004
Patient Outcome  Hospitalization;
Event Description

Dr was doing a bilateral transforaminal epidural steroid injection using a 26ga needle when the needle broke off in the pt at l4-l4 dorsal midline. Approx 2. 5mm of needle was left in the pt. The procedure was completed.

 
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Brand NameBD MED SYSTEMS
Type of DeviceSPINAL NEEDLE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BD MEDICAL SYSTEMS
franklin lakes NJ *
Manufacturer (Section D)
BD MEDICAL SYSTEMS
franklin lakes NJ *
Device Event Key533085
MDR Report Key543692
Event Key516365
Report Number543692
Device Sequence Number1
Product CodeBSP
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/12/2004,09/14/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/15/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date05/01/2009
Device Catalogue Number405164
Device LOT Number4149082
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/15/2004
Distributor Facility Aware Date07/30/2004
Device Ageunknown
Event Location Hospital
Date Report TO Manufacturer09/15/2004
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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