NUTRILINE
Report
- Report Number
- 2245270-2022-00059
- Event Type
- Malfunction
- Date Received
- July 11, 2022
- Date of Event
- March 27, 2022
- Report Date
- October 14, 2022
- Manufacturer
- VYGON USA
- Product Code
- LJS
- PMA / PMN Number
- K051690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS MALFUNCTION WAS FIRST REPORTED TO FDA BY THE CUSTOMER VIA MEDWATCH (B)(4). THE FAILED DEVICE WILL BE RETURNED TO VYGON FOR EVALUATION AND COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING,AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION.
THIS MALFUNCTION WAS FIRST REPORTED TO FDA BY THE CUSTOMER VIA MEDWATCH 1000060000-2022-8032. THE COMPLAINT WAS FORWARDED TO OUR PARENT COMPANY IN GERMANY FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: WE RECEIVED ONE NUTRILINE CATHETERS FOR EVALUATION. THE FAULTY SAMPLE RETURNED BY THE CUSTOMER WAS SHORTENED BY THE USER AT 16 CM. DURING THE SAMPLE EXAMINATION, WE FOUND THAT THE CATHETER WAS LEAKING NEXT TO THE FIXATION IN AN ATTEMPT TO FLUSH IT WITH WATER USING A 10 ML SYRINGE. THERE WAS A MICROHOLE AT THE JUNCTION OF THE CATHETER WITH THE FIXATION WING. THE CATHETER TUBE WAS PARTLY TORN OUT OF THE FIXATION WING. MICROSCOPIC EXAMINATION OF THE FRACTURE PLANE SHOWED A ROUGH AND UNEVEN SURFACE, WHICH IS A TYPICAL SIGN FOR A TENSILE FRACTURE DUE TO A HIGH TENSILE LOAD. DOCUMENTATION FOR BATCH NO. 8138680 SHOWED THAT THE CODE 4G31252400, BATCH 8132711 WAS USED TO MANUFACTURE THIS BATCH. AN INTERNAL PRODUCT RECALL (NO. 012, NON-CONFORMITY NO. 9424) WAS ISSUED MID-MARCH 2021. AS WE DID NOT SEE ANY INDENTATION MARKS AT 6 MM DISTAL TO THE FIXATION WING, WE CAN EITHER RULE OUT THAT THIS RETURNED CATHETER CAME FROM CODE 4G31252400, BATCH NO. 8132711 OR THE SAMPLE WAS OVERMOLDED IN THE UNAFFECTED CAVITY OF THE MOLD. A REVIEW OF THE BATCH HISTORY RECORDS FOR BATCH NO. 8150602 WERE PERFORMED, AND NO DEVIATIONS WERE FOUND. THE BATCH COMPLIED TO ITS SPECIFICATION AND WAS RELEASED. EACH CATHETER IS LEAK AND FLOW TESTED DURING PRODUCTION. THE TENSILE FORCE OF THE CATHETER COMPONENTS IS RANDOMLY CHECKED. THE TENSILE FORCE FOR THE JUNCTION OF CATHETER TUBE AND WING (CODE 4G31252400, BATCHES NO. 8147241 HAS A MEAN OF 5,20 N). THE MEAN FOR BATCH NO. 8150917 WAS 5,13N. AT ITS MINIMUM AT 3 N, THIS IS WITHIN THE SPECIFICATION. VISUAL TESTS AND INCOMING GOODS INSPECTIONS ARE CARRIED OUT WITH NO EXCEPTIONS FOUND. CORRECTIVE ACTION: AS EACH CATHETER IS LEAK AND FLOW TESTED BEFORE PACKAGING AND THE CATHETER WAS USED UNEVENTFULLY FOR 13 DAYS BEFORE LEAKAGE OCCURRED, WE DO NOT BELIEVE THIS DEFECT IS A MANUFACTURING RELATED. ANY MANUFACTURING PROBLEMS THAT WOULD LEAD TO A LEAK WOULD BE DETECTED BYTHE USER WHEN FLUSHING THE CATHETER. THEREFORE, NO FURTHER CORRECTIVE ACTION IS INITIATED BY QUALITY MANAGEMENT.
DRESSING CHANGE PER PROTOCOL. PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) NOTED TO BE LEAKING AT HUB. PICC DISCONTINUED. CATHETER REMOVED IN ITS ENTIRETY. THE PICC LINE WAS REMOVED WITHOUT INCIDENT. A PIV (PERIPHERALLY INTRAVENOUS LINE) WAS PLACED.
DRESSING CHANGE PER PROTOCOL. PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) NOTED TO BE LEAKING AT HUB. PICC DISCONTINUED. CATHETER REMOVED IN ITS ENTIRETY. THE PICC LINE WAS REMOVED WITHOUT INCIDENT. A PIV (PERIPHERALLY INTRAVENOUS LINE) WAS PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2397237 | NUTRILINE | LONG-TERM INTRAVASCULAR CATHETER | LJS | VYGON USA | 1252.35G | 21I004D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |