KITTNER(BLUNT) DISSECTOR, 9/16 X 1/4" IN FOAM HOLDER 5/P
Report
- Report Number
- 3010452421-2024-00004
- Event Type
- Malfunction
- Date Received
- August 12, 2024
- Date of Event
- June 25, 2024
- Report Date
- August 15, 2024
- Manufacturer
- MEIXIN MEDICAL SUZHOU CO., LTD.
- Product Code
- GDY
- UDI-DI
- 00749756024396
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
A USER FACILITY REPORTED, "KITTNER SPONGES ARE BREAKING OFF WITH MINIMAL FORCE AND SURGEON IS FINDING PIECES. THIS IS FOR DR ZAYA'S TOTAL THYROIDECTOMY." DEROYAL INDUSTRIES HAS REQUESTED RETURN OF THE SAMPLE BUT IT HAS NOT YET BEEN RETURNED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE KITTNER SUPPLIER MEIXIN MEDICAL SUZHOU CO. , LTD. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE KITTNER SUPPLIER MEIXIN MEDICAL SUZHOU CO. , LTD. DEROYAL INDUSTRIES REQUESTED RETURN OF THE SAMPLE AND RECEIVED IT ON JULY 8, 2024. DEROYAL REVIEWED THE SAMPLE AND FOUND THAT THERE WAS A BLUE SPEC OVER THE GAUZE. THE SUPPLIER WAS CONTACTED THROUGH THE SCAR. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED. THE QUALITY CONTROL INSPECTION REPORT OF THE LOT NUMBER WAS INSPECTED. PACKS WERE INSPECTED AND ALL WERE FOUND TO BE ACCEPTABLE. AN INVENTORY CHECK WAS ALSO PERFORMED AND NO ISSUES WERE FOUND. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. THE SCAR WAS RETURNED FROM THE VENDOR. MEIXIN MEDICAL SUZHOU CO. LTD. CONFIRMED THAT IT COULD SEEN THAT BLUE X-RAY DEBRIS WERE FALLING ONTO THE GAUZE PIECE, BUT IT COULD NOT BE CONFIRMED THAT KITTNER SPONGES WERE BREAKING OFF. AN INVESTIGATION WAS CONDUCTED BY THE VENDOR TO DETERMINE THE QUALITY ISSUE OF THE X-RAY DEBRIS. A COMPLAINT TO SALES RATIO WAS CONDUCTED FROM JANUARY 2022 THROUGH JULY 2024 AND FOUND TO BE LESS THAN 0.03%. ROOT CAUSE: IT WAS DETERMINED BY MEIXIN MEDICAL THAT WHEN KITTNER SPONGES ARE BEING MADE, THE X-RAY THREAD NEEDS TO BE TRIMMED BEFORE THE THREAD IS SEW ONTO THE GAUZE. IF THE SUITABLE LENGTH IS NOT TRIMMED CORRECTLY THE FIRST TIME, IT MAY NEED TO BE RETRIMMED. THIS COULD RESULT IN DEBRIS OF BLUE X-RAY THREAD BEING LEFT ON THE SPONGES. CORRECTIVE AND PREVENTIVE ACTIONS TAKEN BY MEIXIN MEDICAL: NOTIFICATIONS OF THE X-RAY DEBRIS ISSUE HAS BEEN MADE TO ALL PERSONNEL ON THE KITTNER SPONGE PRODUCTION LINE WHICH IS REQUIRING WORKERS TO BE MORE CAREFUL WHEN SEWING AND CUTTING THE X-RAY THREAD. IT ALSO STATED THAT IN THE CASE OF ACCIDENTAL BREAKAGE OR REPETITIVE TRIMS, X-RAY DEBRIS SHOULD BE PROMPTLY PICKED OUT. THE INSPECTION PROCESS ALSO REQUIRES THAT DURING FULL-INSPECTION AND PACKAGING PROCESS, WORKERS SHALL CAREFULLY INSPECT EACH SPONGE AND PROMPTLY REMOVE ANY FOREIGN DEBRIS ATTACHED. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
A USER FACILITY REPORTED, "KITTNER SPONGES ARE BREAKING OFF WITH MINIMAL FORCE AND SURGEON IS FINDING PIECES. THIS IS FOR DR (B)(6) TOTAL THYROIDECTOMY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2027266 | KITTNER(BLUNT) DISSECTOR, 9/16 X 1/4" IN FOAM HOLDER 5/P | GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE | GDY | MEIXIN MEDICAL SUZHOU CO., LTD. | 30-101 | 56666266 | 00749756024396 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |