NUTRILINE
Report
- Report Number
- 2245270-2023-00076
- Event Type
- Malfunction
- Date Received
- October 25, 2023
- Date of Event
- August 1, 2023
- Report Date
- January 2, 2024
- Manufacturer
- VYGON USA
- Product Code
- LJS
- PMA / PMN Number
- K051690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
WE RECEIVED ONE CATHETER AS A SAMPLE. WE RECEIVED THE CATHETER INCLUDING THE STYLET. THE Y-PIECE IS MISSING. THE STYLET PROTRUDES FROM THE CATHETER 4.5 CM. THE REMAINING STYLET CAN BE REMOVED WITHOUT ANY PROBLEM. THE STYLET WAS KINKED. DUE TO NOT RECEIVING THE Y-PIECE VYGON IS UNABLE TO THOROUGHLY INVESTIGATE A POSSIBLE MANUFACTURING DEFAULT OF THE STYLET. THE FOLLOWING INFORMATION IS PROVIDED IN THE PRODUCT IFU REGARDING STYLET REMOVAL, CAUTION: "IF THE DIFFICULTY IS EXPERIENCED REMOVING THE STYLET STOP, LET VEIN REST FOR A MINUTE, AND TRY REMOVAL AGAIN VERY SLOWLY. GENTLE FLUSHING OF THE CATHETER WITH SALINE MAY ASSIST IN STYLET REMOVAL.". A REVIEW OF THE BATCH HISTORY RECORDS FOR 8198425 & 8206332 WAS PERFORMED, 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 CATHETER COMPONENTS ARE RANDOMLY CHECKED DURING PRODUCTION. THE MIN. VALUE OF 3.10 N AND THE MAX. VALUE OF 9.00 N IS REQUESTED REGARDING THE TENSILE FORCE FOR THE STYLET OUT OF Y-PIECE ACCORDING TO OUR SPECIFICATION. FOR THE INVOLVED CODE 4G31252030, FOR BATCH 8191847 THE RANGE WAS BETWEEN 2.74 N AND 6.80 N, FOR BATCH 8196204 THE RANGE WAS BETWEEN 3.12 N AND 6.65 N AND FOR BATCH 8201130 THE RANGE WAS BETWEEN 2.62 N AND 8.15 N, AND THEREFORE WITHIN THE SPECIFICATION, WITH EXCEPTION OF ONE VALUE FOR BATCH 8191847 AND TWO VALUES FOR BATCH 8201130. INCOMING GOODS INSPECTIONS AND TWO 100 % VISUAL TESTS AFTER PACKAGING ARE CONDUCTED WITH NO EXCEPTIONS FOUND. MOREOVER, IT IS A SAFETY FEATURE THAT THE TENSILE STRENGTH OF THE STYLET EXCEEDS THE TENSILE STRENGTH OF THE CONNECTION BETWEEN THE STYLET AND THE Y-PIECE. THIS ENSURES THAT THE STYLET DO NOT SNAP INTO ITSELF. THERE ARE THREE FURTHER COMPLAINTS FOR BATCH 8198425, TWO FURTHER COMPLAINTS FOR BATCH 8206332 AND THREE FURTHER COMPLAINTS REGARDING A DETACHED STYLET ON CODE 4G07125203 WITHIN THE LAST THREE YEARS. THIS QUERY RELATES TO ALL THE COMPLAINTS THAT HAVE COME TO OUR ATTENTION WORLDWIDE. CORRECTIVE ACTION: BASED ON VYGON GERMANY'S INVESTIGATION, THIS ISSUE HAS BEEN COMMUNICATED TO THE PRODUCTION MANAGER AND ALL PRODUCTION PERSONNEL INVOLVED IN THIS ISSUE. BOTH VYGON GERMANY AND VYGON USA HAVE ENTERED THIS INCIDENT INTO OUR COMPLAINT LOGS AND WILL CONTINUE TO BE VIGILANT FOR THIS TYPE OF COMPLAINT.
THE MALFUNCTIONING DEVICE WILL BE RETURNED TO VYGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE PENDING AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION VIA FOLLOW UP MDR.
PLACED A PICC LINE INTO INFANTS LEFT SAPHENOUS VEIN (INSERTED NEAR ANKLE), WHILE TRYING TO REMOVE GUIDEWIRE/STYLET FROM CATHETER, GUIDEWIRE/STYLET SNAPPED FROM PLASTIC. UNABLE TO REMOVE GUIDEWIRE/STYLET FROM CATHETER. NEEDED TO REMOVE ENTIRE CATHETER AND PLACE NEW LINE AT NEW SITE IN LEG (LEFT SAPHENOUS, JUST BELOW KNEE). THIS RESULTED IN A SECOND PAINFUL POKE.
PLACED A PICC LINE INTO INFANTS LEFT SAPHENOUS VEIN (INSERTED NEAR ANKLE), WHILE TRYING TO REMOVE GUIDEWIRE/STYLET FROM CATHETER, GUIDEWIRE/STYLET SNAPPED FROM PLASTIC. UNABLE TO REMOVE GUIDEWIRE/STYLET FROM CATHETER. NEEDED TO REMOVE ENTIRE CATHETER AND PLACE NEW LINE AT NEW SITE IN LEG (LEFT SAPHENOUS, JUST BELOW KNEE). THIS RESULTED IN A SECOND PAINFUL POKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1433064 | NUTRILINE | INTRAVASCULAR CATHETER | LJS | VYGON USA | 1252.030G | 23C035D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |