BD SPINAL/EPIDURAL NEEDLES & TRAYS
Received Jul 18, 2025 · Event occurred Feb 17, 2025
Report 9610048-2025-00093 · MDR key 22549129
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton Dickinson Industrias Cirurgicas, Ltda.Catalog number
408375
Lot number
4145799
Product problems
- Leak/Splash
- Connection Problem
- Leak/Splash
- Connection Problem
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. E1. ALL DEMOGRAPHIC INFORMATION ON THE REGULATORY DOCUMENT STATES "CONFIDENTIAL".
Description of Event or Problem
IT WAS REPORTED THAT BD SPINAL NEEDLE HAD A POOR CONNECTION TO THE SYRINGE AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DOES NOT FIT THE SYRINGE PERFECTLY, CAUSING CHEMOTHERAPY MEDICATION TO LEAKING.
Description of Event or Problem
NO ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
INVESTIGATION RESULTS: IN ADDITION TO NO RECORDS BEING IDENTIFIED THAT COULD HAVE CAUSED THIS COMPLAINT DURING THE REVIEW OF THE BATCH HISTORY, CORRECTIVE MAINTENANCE, AND NONCONFORMANCE RECORDS, BASED ON THE COMPLAINT DESCRIPTION, IT WAS NOT POSSIBLE TO ASSOCIATE THE DEFECT WITH THE PACKAGING PROCESS PERFORMED AT (B)(4). BASED ON THE INVESTIGATION RESULTS SO FAR, IT HAS NOT BEEN POSSIBLE TO DETERMINE A ROOT CAUSE FOR THIS COMPLAINT.