NUTRILINE CATHETER
Report
- Report Number
- 2245270-2024-00019
- Event Type
- Malfunction
- Date Received
- February 20, 2024
- Date of Event
- January 29, 2024
- Report Date
- June 7, 2024
- Manufacturer
- VYGON USA
- Product Code
- LJS
- PMA / PMN Number
- K051690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS MALFUNCTION WAS FIRST REPORTED TO FDA BY THE CUSTOMER VIA MEDWATCH-(B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO VYGON, BUT THE COMPLAINT DETAILS HAVE BEEN SENT TO VYGON GMBH FOR COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION.
THIS MDR REPORT WAS SENT UNDER NUMBER 2245270-2024-00019 ON 05/29/2024. CORRECTED MDR-2245270-2024-00019, WHICH NOW INCLUDES THE MEDWATCH REPORT (B)(4) IN BLOCK H10 UNDER THE RELATED REPORT NUMBER FIELD.
THIS MALFUNCTION WAS FIRST REPORTED TO FDA BY THE CUSTOMER VIA MEDWATCH (B)(4). WE CONTACTED THE CUSTOMER AND ASKED FOR MORE DETAILS ABOUT THE INCIDENT. UNFORTUNATELY, DESPITE OUR REQUEST, WE HAVE NOT RECEIVED THE SAMPLE AND ADDITIONAL INFORMATION. THE CUSTOMER HAS INFORMED US THAT THE DEFECTIVE PRODUCT WAS DISPOSED OF AFTER IT FAILED. DUE TO THE LACK OF A SAMPLE AND ADDITIONAL INFORMATION, THIS COMPLAINT CANNOT BE CONFIRMED, AND THE EXACT ROOT OF THE ISSUE CANNOT BE DETERMINED. THERE ARE VARIOUS EVENTS THAT CAN LEAD TO CATHETER LEAKAGE: TENSILE FORCE: WHICH MAY BE CAUSED BY: DRESSING CHANGE: IN SOME INSTANCES, THE CATHETER CAN BECOME ADHERED TO THE DRESSING AND ADDITIONAL PULLING IS REQUIRED TO FREE IT; PLACING STRESS ON THE LINE COULD RESULT IN A TENSILE FRACTURE. ROUTINE CARE (WHEN LIFTING THE BABY TO CHANGE THE BEDDING) AND MOVEMENT OF THE BABY ITSELF COULD RESULT IN A TENSILE FRACTURE. MECHANICAL DAMAGE BY A SHARP INSTRUMENT (FOR EXAMPLE SCISSORS, TOOTHED FORCEPS, OR SCALPEL) DURING DRESSING CHANGE. USE ALCOHOL-BASED DISINFECTANT. A REVIEW OF THE BATCH HISTORY RECORDS WAS PERFORMED FOR COMPONENT LOTS 8106773, AND 8134055, AND NO DEVIATIONS WERE FOUND. THE BATCHES COMPLIED WITH ITS SPECIFICATIONS AND WERE RELEASED. EACH CATHETER IS FLOW AND LEAK-TESTED DURING PRODUCTION. THE TENSILE FORCE AND DIMENSIONS OF THE CATHETER COMPONENTS ARE RANDOMLY CHECKED. INCOMING GOODS INSPECTIONS AND TWO 100% VISUAL TESTS AFTER PACKAGING ARE CONDUCTED WITH NO EXEMPTIONS FOUND. THERE ARE THREE FURTHER COMPLAINTS FOR BATCH 8106773, BUT NO FURTHER COMPLAINTS FOR BATCH 8134055 AND NO FURTHER COMPLAINTS REGARDING A LEAKING CATHETER AT THE WING ON CODE 4G07125231 WITHIN THE LAST THREE YEARS. THIS QUERY RELATES TO ALL COMPLAINTS THAT HAVE COME TO OUR ATTENTION WORLDWIDE. CORRECTIVE ACTION: THIS COMPLAINT COULD NOT BE CLASSIFIED DUE TO THE LACK OF A SAMPLE AND ADDITIONAL INFORMATION. THEREFORE, VYGON GERMANY QUALITY MANAGEMENT DID NOT INITIATE ANY FURTHER CORRECTIVE ACTION AT THIS TIME. IF YOU STILL HAVE LOT 21C034D IN YOUR INVENTORY, PLEASE STOP USING IT IMMEDIATELY, AS IT EXPIRED ON APRIL 30, 2024.
WHILE CHANGED THE DRESSING, TPN FLUIDS STARTED LEAKING FORM CONNECTION OF THE CATHETER AND THE BUTTERFLY.
WHILE CHANGED THE DRESSING, TPN FLUIDS STARTED LEAKING FORM CONNECTION OF THE CATHETER AND THE BUTTERFLY.
WHILE CHANGED THE DRESSING, TPN FLUIDS STARTED LEAKING FORM CONNECTION OF THE CATHETER AND THE BUTTERFLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1086989 | NUTRILINE CATHETER | INTRAVASCULAR CATHETER | LJS | VYGON USA | 1252.31G | 21C034D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 DA | Male | Required Intervention |