NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE
Received Jan 13, 2025 · Event occurred Dec 30, 2024
Report 2618282-2025-00002 · MDR key 21138370
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Becton DickinsonCatalog number
405079
Lot number
4183543
Product problems
- Difficult to Insert
- Difficult to Insert
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
Description of Event or Problem
NEEDLE STUCK WHEN TRYING TO REMOVE FROM SHEATH (SEE PICTURE). NEEDLE RESISTANCE WHEN TRYING TO INSERT INTO INTRODUCER. SCRATCHING FEELING WHEN REMOVING FROM INTRODUCER WHICH BLUNTS THE NEEDLE. OLD PACKAGING OF 405079 (BATCH: 1120615) DOES NOT HAVE ABOVE PROBLEM, PUT TOGETHER IN BOX FOR REFERENCE AND COMPARISON. 405260 INTRODUCER NEEDLE PUT TOGETHER FOR TESTING SCRATCHING SOUND.
Description of Event or Problem
NO ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
INVESTIGATION RESULTS: TEN SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. NINE 27GA X 3.5¿ NEEDLES WERE FROM BATCH 4183543, THE LOT WITH THE REPORTED ISSUE. OUT OF THE NINE, FOUR NEEDLES WERE UNUSED AND SEALED IN THEIR BLISTER AND FIVE NEEDLES WERE OUT OF THE BLISTERS. ONE 27GA X 3.5¿ UNUSED AND SEALED NEEDLE FOR BATCH 1120615, THE LOT THAT WAS REPORTED TO NOT HAVE THE ISSUE, AND THE INTRODUCER WAS ALSO RECEIVED. IT WAS OBSERVED THAT THE NEEDLES HAD THEIR COMPONENTS (NEEDLE, STYLET AND SHIELD). THE SAMPLES WERE SUBMITTED FOR VISUAL INSPECTION AND TESTING. ONE OF THE OPENED NEEDLES FROM THE REPORTED LOT, 4183543, WAS BENT AT THE TIP OF THE HUB WHICH WAS PREVENTING FULL INSERTION OF THE STYLET; THEREFORE, THE REPORTED INCIDENT COULD BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE REPORTED ISSUE WAS DUE TO THE BENT NEEDLE. THE ROOT CAUSE OF THE BENT NEEDLE IS POTENTIALLY RELATED TO HANDLING ISSUES AS THERE WERE NO ISSUES WITH THE UNUSED SAMPLES PROVIDED. AS IT IS EXPLAINED IN THE IFU, CARE SHOULD BE TAKEN TO AVOID NEEDLE DAMAGE. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.