NUTRILINE
Report
- Report Number
- 2245270-2023-00075
- Event Type
- Malfunction
- Date Received
- October 25, 2023
- Date of Event
- June 15, 2023
- Report Date
- December 29, 2023
- Manufacturer
- VYGON USA
- Product Code
- LJS
- PMA / PMN Number
- K051690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
WE RECEIVED ONE CATHETER AS A SAMPLE. THE CATHETER WAS SHORTENED AT THE 9 CM MARKING. THE STYLET WAS KINKED. MOREOVER, THE CATHETER WAS EASILY FLUSHED WITHOUT ANY SIGNS OF LEAKAGE. THE STYLET OBVIOUSLY CAME OUT OF THE Y-PIECE. DURING THE MICROSCOPIC EXAMINATION OF THE Y-PIECE, WE NOTICED A DISTINCT IMPRINT INSIDE THE GLUING OF THE CAP. THIS CONFIRMS THAT THE STYLET WAS SECURELY CLAMPED IN PLACE. 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 8178395 & 8198425 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. FOR THE INVOLVED CODE 4G31252030, FOR BATCH 8181219 THE RANGE WAS BETWEEN 4.33 N AND 7.04 N, FOR BATCH 8191847 THE RANGE WAS BETWEEN 2.74 N AND 6.80 N, AND FOR BATCH 8196204 THE RANGE WAS BETWEEN 3.12 N AND 6.65 N. OVERALL, THESE MEASUREMENTS FALL WITHIN THE SPECIFIED RANGE, EXCEPT FOR ONE VALUE IN BATCH 8191847. THIS ENSURES THAT THE STYLET DOES NOT SNAP BY ITSELF. THE INCOMING GOODS INSPECTIONS AND TWO 100% VISUAL TESTS AFTER PACKAGING ARE CONDUCTED WITH NO EXCEPTIONS FOUND. THERE ARE THREE FURTHER COMPLAINTS FOR BATCH 8198425, FOUR FURTHER COMPLAINTS FOR BATCH 8178395 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, THE PRODUCTION MANAGER AND ALL THE RESPONSIBLE PERSONNEL HAVE BEEN INFORMED OF 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.
THIS RN ATTEMPTED TO PLACE A VYGON 2FR. SINGLE LUMEN PICC LINE VIA PATIENT'S LEFT SAPHENOUS VEIN. PICC WAS PLACED IN OPTIMAL POSITION BUT WHEN REMOVING STYLET IT BROKE OFF FROM THE HUB. STYLET WAS ABLE TO BE COMPLETELY REMOVED BUT RESULTED IN REMOVAL OF THE PICC LINE. THIS PATIENT REMAINS WITHOUT CENTRAL ACCESS DUE TO THIS EVENT.
THIS RN ATTEMPTED TO PLACE A VYGON 2FR. SINGLE LUMEN PICC LINE VIA PATIENT'S LEFT SAPHENOUS VEIN. PICC WAS PLACED IN OPTIMAL POSITION BUT WHEN REMOVING STYLET IT BROKE OFF FROM THE HUB. STYLET WAS ABLE TO BE COMPLETELY REMOVED BUT RESULTED IN REMOVAL OF THE PICC LINE. THIS PATIENT REMAINS WITHOUT CENTRAL ACCESS DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1047727 | NUTRILINE | LONG-TERM INTRAVASCULAR CATHETER | LJS | VYGON USA | 1252.030G | 23B017D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |