SPINAL ANESTHETIC NEEDLE

Additional Manufacturer Narrative

WE HAVE QUESTIONED OUR LOCAL SUBSIDIARY (DISTRIBUTOR) IN IRELAND IN ORDER TO RECEIVE ADDITIONAL INFORMATION. THE BATCH REVIEW OF THESE DEVICES IS COMPLIANT. NO DEVIATION HAS BEEN REGISTERED. THE NEEDLES COMPLY WITH ITS SPECIFICATIONS. THE HISTORICAL DATA ANALYSIS OF COMPLAINTS ON THIS BATCH DOES NOT SHOW ANY COMPLAINT. THIS IS THE FIRST COMPLAINT FROM (B)(4) UNITS OF THIS BATCH SOLD SINCE SEPTEMBER 2023. WE ARE WAITING FOR THE INVOLVED SAMPLE AND FOR THE ADDITIONAL INFORMATION FOR INVESTIGATION.

Description of Event or Problem

THE NEEDLE SNAPPED IN HALF DURING PROCEDURE. A FRAGMENT OF THE NEEDLE WAS RETAINED IN THE PATIENT'S SOFT TISSUES. THE FRAGMENT WAS REMOVED USING FORCEPS AND IMAGING. INJURY WAS SUFFERED.

Description of Event or Problem

THE NEEDLE SNAPPED IN HALF DURING PROCEDURE. A FRAGMENT OF THE NEEDLE WAS RETAINED IN THE PATIENT'S SOFT TISSUES. THE FRAGMENT WAS REMOVED USING FORCEPS AND IMAGING. INJURY WAS SUFFERED.

Additional Manufacturer Narrative

THE INVOLVED SPINAL NEEDLE HAS BEEN KEPT AND IT HAS BEEN SENT FOR INVESTIGATION. WE RECEIVED THE SPINAL NEEDLE BROKEN IN 2 PARTS WITH ITS STYLET OUTSIDE THE SPINAL NEEDLE. FROM ADDITIONAL INFORMATION RECEIVED FROM COMPLAINANT, THE PATIENT WAS A LADY WITH A BIG BMI AND IT WAS DIFFICULT INSERTION WITH A NUMBER OF FAILED ATTEMPTS AT PLACING A SPINAL NEEDLE. FROM VISUAL EXAMINATION, THE BROKEN NEEDLE FRAGMENT REMOVED FROM THE PATIENT HAS BEEN STRONGLY BENT AT 2 LEVEL AND AT APPROX.90°. THE BEVEL OF NEEDLE IS NOT BLUNT. THIS SPINAL NEEDLE IS SUPPLIED WITH AN INTRODUCER. THE SPINAL NEEDLE SHOULD BE INSERTED THROUGH THIS INTRODUCER TO REDUCE THE RISKS OF KINKING OF THE SPINAL NEEDLE.IT IS NOT CLEARLY WRITTEN THAT IT WAS USED . FROM USER'S DESCRIPTION, THE PUNCTURE PROCEDURE WAS DIFFICULT WITH NUMBER OF FAILED ATTEMPS ON AN OVERWEIGHT PATIENT. THIS IS CHARACTERISTIC OF THE STAINLESS STEEL TUBE OF THE SPINAL NEEDLE BEING BENT. THEN WHEN THE USER TRIED TO REMOVE IT , HE HAS PROBABLY STRAIGHTEN IT BY APPLYING MECHANICAL FORCE AND IT BROKE. THE ORIGIN OF THIS RUPTURE IS NOT RELATED TO A DEFECT OF THE SPINAL NEEDLE. IT IS RELATED TO THE DIFFICULT PUNCTURE PROCEDURE. THE BATCH REVIEW CONFIRMS THAT THESE SPINAL NEEDLES ARE IN COMPLIANCE WITH ISO 9626 NORM. THE HISTORICAL ANALYSIS OF THE LAST 3 YEARS, SHOWS THAT THIS IS THE FIRST COMPLAINT AND INCIDENT ON THIS REFERENCE. IT IS AN ISOLATED CASE.ON REFERENCE 181.052 WHICH CONTAINS ALSO A 25G SPINAL NEEDLE, THERE IS ONLY ONE SIMILAR INCIDENT IN 2023 IN FRANCE. IT WAS NOT RELATED TO THE DEVICE BUT TO VERY DIFFICULT PUNCTURE PROCEDURE WITH 5 ATTEMPS ON A PATIENT IN PSYCHIATRY, HIGHLY AGITATED AND HELD BY 2 NURSES. THE BATCH ANALYSIS, SHOWS THAT THERE IS NO SIMILAR INCIDENT AND NO OTHER COMPLAINT ON THIS BATCH OF (B)(4) UNITS . THIS BATCH HAS BEEN SUPPLIED BEETWEN AUGUST AND NOVEMBER OF LAST YEAR.