TECA CONCENTRIC NEEDLES
Report
- Report Number
- 3005581270-2024-00001
- Event Type
- Malfunction
- Date Received
- January 2, 2024
- Date of Event
- December 22, 2023
- Report Date
- March 1, 2024
- Manufacturer
- NATUS MANUFACTURING LIMITED
- Product Code
- IKT
- PMA / PMN Number
- K112034
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INITIAL REPORT REF NATUS COMPLAINT# (B)(4). A QUESTIONNAIRE HAS BEEN SENT TO THE CUSTOMER TO COMPLETE AND ALSO A REQUEST FOR THE REMAINING UNUSED NEEDLES TO BE RETURNED FOR EVALUATION.
FOLLOW UP REPORT 002 REF NATUS (B)(4). A QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO COMPLETE AND ALSO A REQUEST FOR THE REMAINING UNUSED NEEDLES TO BE RETURNED FOR EVALUATION. VARIOUS FOLLOW UP ATTEMPTS WERE MADE TO GET A RESPONSE, REQUESTING PICTURES, WAS SURGERY NEEDED TO REMOVE THE NEEDLE, AND CURRENT CONDITION OF THE PATIENT. NO RESPONSE RECEIVED FROM THE CUSTOMER. REVIEW OF DEVICE HISTORY RECORD WAS CARRIED OUT AS FOLLOWS: WO (B)(4) WAS REVIEWED AND DOES NOT SHOW ANY ANOMALIES FOR THE COMPLAINT INCLUDING A REVIEW OF ALL APPLICABLE MEASUREMENTS AND VISUAL INSPECTIONS POST KOMAX 4 AS PER VISUAL AID DOC-011099. ALL NEEDLES WERE PROCESSED THOUGH MANUFACTURING PROCESS WITH NO MAJOR FALLOUT REPORTED ON ANY OP SEQUENCE. ALL STEPS CARRIED OUT BY HIGHLY EXPERIENCED OPERATORS. WORK ORDER NOT SUBJECT TO ANY NCR/CAPA OR VALIDATION. THERE WERE NO YIELD ISSUES REPORTED ON WORK ORDER (98.70%). NO QUANTITIES OF THIS LOT REMAIN IN GORT OR MIDDLETON AND NO OTHER COMPLAINTS PERTAINING TO THIS ORDER (OR TECA NEEDLES PRODUCED IMMEDIATELY BEFORE OR AFTER). NO MAINTENANCE TOOK PLACE ON KOMAX 4 WHILE ORDER WAS MANUFACTURED. ALL NEEDLE TO HUB RESULTS WITHIN DHR WERE IN SPEC THERE WERE NO INCOMING INSPECTION ISSUES ON HUB LOTS (2234064 / 2246018 / 2303045) AND NO INCOMING INSPECTION ISSUES ON NEEDLE BLANK LOT (101928D). IMPACT TO OTHER PRODUCT(S): FROM PERIOD 2021 TO PRESENT, THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH TECA CONCENTRIC NEEDLES BREAKING IN A PATIENTS MUSCLE. INVESTIGATION SUMMARY: NO PRODUCT EXAMINATION AS THE AFFECTED PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY ANOMALIES FOR THE COMPLAINT INCLUDING A REVIEW OF ALL APPLICABLE MEASUREMENTS, AND NO COMPLAINTS FOR THIS ISSUE HAVE BEEN RECEIVED IN THE 12-MONTH PERIOD.
FOLLOW UP REPORT 001 REF NATUS COMPLAINT#(B)(4). RISK REVIEW: PER (B)(4) REV 14 RISK ANALYSIS SPREADSHEET FOR TECA DCN ELECTRODES HAZARD 6.7 - NEEDLES ARE THIN AND FLEXIBLE; NEEDLE MAY PULL OUT OF HUB SUB-ASSEMBLY (LOSS OF MECHANICAL INTEGRITY). EFFECTS (HARM): WORST CASE - CANNULA AND HUB SUB-ASSEMBLY DETACH, CANNULA IS DRAWN INSIDE PATIENT (BY PATIENT MUSCLE MOVEMENT) AND HAS TO BE REMOVED SURGICALLY. RESIDUAL RISK: MODERATE. A QUESTIONNAIRE WAS SENT TO THE CUSTOMER TO COMPLETE AND ALSO A REQUEST FOR THE REMAINING UNUSED NEEDLES TO BE RETURNED FOR EVALUATION. VARIOUS FOLLOW UP ATTEMPTS WERE MADE TO GET A RESPONSE FROM THE CUSTOMER. THE CUSTOMER HAS NOT YET CONFIRMED IF THEY WILL RETURN ANY PRODUCT FOR EXAMINATION.
PART S53153, CONCENTRIC NEEDLES. THE NEEDLE DETACHED FROM ITS PLASTIC SUPPORT AND REMAINED INSERTED IN THE PATIENT'S DELTOID MUSCLE, MAKING IT IMPOSSIBLE TO REMOVE IT IN THE NEUROPHYSIOLOGY CONSULTATION. THE PATIENT IS IN PAIN. THROUGH X-RAY AND CT, THE CONDITION OF THE NEEDLE HAS BEEN CONFIRMED INTRAMUSCULARLY. THE NEEDLE WILL BE RETRIEVED IF SURGERY IS ULTIMATELY NEEDED.
PART S53153, CONCENTRIC NEEDLES. THE NEEDLE DETACHED FROM ITS PLASTIC SUPPORT AND REMAINED INSERTED IN THE PATIENT'S DELTOID MUSCLE, MAKING IT IMPOSSIBLE TO REMOVE IT IN THE NEUROPHYSIOLOGY CONSULTATION. THE PATIENT IS IN PAIN. THROUGH X-RAY AND CT, THE CONDITION OF THE NEEDLE HAS BEEN CONFIRMED INTRAMUSCULARLY. THE NEEDLE WILL BE RETRIEVED IF SURGERY IS ULTIMATELY NEEDED.
PART S53153, CONCENTRIC NEEDLES. THE NEEDLE DETACHED FROM ITS PLASTIC SUPPORT AND REMAINED INSERTED IN THE PATIENT'S DELTOID MUSCLE, MAKING IT IMPOSSIBLE TO REMOVE IT IN THE NEUROPHYSIOLOGY CONSULTATION. THE PATIENT IS IN PAIN. THROUGH X-RAY AND CT, THE CONDITION OF THE NEEDLE HAS BEEN CONFIRMED INTRAMUSCULARLY. THE NEEDLE WILL BE RETRIEVED IF SURGERY IS ULTIMATELY NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1203705 | TECA CONCENTRIC NEEDLES | TECA CONCENTRIC NEEDLES | IKT | NATUS MANUFACTURING LIMITED | S53153 | 16B/23/T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Female | Other |