PREMICATH
Report
- Report Number
- 2245270-2024-00008
- Event Type
- Malfunction
- Date Received
- January 31, 2024
- Date of Event
- December 11, 2023
- Report Date
- May 2, 2024
- Manufacturer
- VYGON USA
- Product Code
- LJS
- PMA / PMN Number
- K041468
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE FAILED SAMPLE WILL BE RETURNED TO VYGON AND WILL BE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED WITH FDA WITHIN 30 DAYS OF COMPLETION.
WE RECEIVED A SHORT PART OF THE EXTENSION LINE WITH THE LL-HUB AS FAULTY SAMPLE. DRIED ORANGE RESIDUES WERE VISIBLE INSIDE THE EXTENSION LINE. THE EXTENSION LINE WAS FIRST CUT AND SNAPPED ROUGHLY AT ABOUT 8 MM, AS INDICATED BY THE GROOVES AND THE ROUGH FRACTURE SURFACE ON THE OPPOSITE END. FURTHERMORE, THE EXTENSION LINE WAS ALMOST TORN OUT OF THE WHITE LL-HUB. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE SHOWED TRACES OF SQUEEZING AND A TYPICAL ROUGH SURFACE FOR A FRACTURE DUE TO EXCESSIVE TENSILE FORCES. WE ASSUME THAT THE SLIDING CLAMP IS REPEATEDLY CLOSED DIRECTLY DISTAL TO THE LL-HUB, CAUSING THE EXTENSION LINE TO SQUEEZE. THE CLAMP SHOULD ONLY BE USED TO CLOSE THE EXTENSION LINE FOR A SHORT TIME. IT IS ALSO POSSIBLE THAT WHEN THE CLAMP IS CLOSED, THE EXTENSION LINE WAS PULLED DURING HANDLING AND THEREFORE DAMAGED AT THE POINT WHERE IT IS SQUEEZED, WHICH IN THIS CASE ULTIMATELY LEADS TO THE TUBE ALMOST TORN OFF. IT IS IMPORTANT TO NOTE THAT THE SLIDING CLAMP SHOULD NOT BE PUSHED COMPLETELY CLOSED. SLIDING THE CLAMP 'HAND-TIGHT' IS SUFFICIENT TO TEMPORARILY CLOSE THE EXTENSION LINE. UNFORTUNATELY, WE DID NOT RECEIVE THE DISTAL PART OF THE CATHETER OR THE SLIDING CLAMP FOR FURTHER EXAMINATION. MOREOVER, INSIDE THE LL-HUB IT WAS VISIBLE THAT THE EXTENSION LINE IS IN THE CORRECT POSITION DURING AND AFTER INJECTION MOLDING. A MANUFACTURING FAULT CAN BE EXCLUDED AS EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION AND THE CATHETER DID NOT LEAK FOR THREE DAYS AS STATED BY THE CUSTOMER. A REVIEW OF THE BATCH HISTORY RECORDS FOR 8172418 AND 8178412 WAS PERFORMED, AND NO DEVIATIONS WERE FOUND. THE BATCHES COMPLIED WITH ITS SPECIFICATIONS AND WERE RELEASED. EACH CATHETER IS LEAK AND FLOW TESTED DURING PRODUCTION. THE TENSILE FORCE AND DIMENSIONS OF THE CATHETER COMPONENTS IS RANDOMLY CHECKED. THE VALUE OF THE TENSILE FORCE OF THE EXTENSION LINE FOR ALL DIFFERENT BATCHES WERE WITHIN THEIR SPECIFICATION OF MIN. 10 N (REF: ISO 10555-1). INCOMING GOODS INSPECTIONS AND TWO VISUAL TESTS AFTER PACKAGING ARE CARRIED OUT WITH NO EXCEPTIONS FOUND. THERE HAVE BEEN NO FURTHER COMPLAINTS FOR BATCH 8178412, TWO FURTHER COMPLAINTS FOR BATCH 8172418 AND NO FURTHER COMPLAINTS REGARDING A LEAKING EXTENSION LINE ON CODE 4G07126104 WITHIN THE LAST THREE YEARS. THIS QUERY RELATES TO ALL THE COMPLAINTS THAT HAVE COME TO OUR ATTENTION WORLDWIDE. CORRECTIVE ACTION: BASED ON THE INVESTIGATION, A MANUFACTURING FAULT CAN BE EXCLUDED AS EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION AND THE CATHETER DID NOT LEAK FOR THREE DAYS AS STATED BY THE CUSTOMER. ANY MANUFACTURING PROBLEMS THAT WOULD LEAD TO A LEAK WOULD BE DETECTED BY THE USER WHEN INITIALLY FLUSHING THE CATHETER BEFORE USE. THEREFORE, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT AT THIS TIME.
PICC LINE BROKE NEAR THE INSERTION SITE AND WAS LEAKING.
PICC LINE BROKE NEAR THE INSERTION SITE AND WAS LEAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 392302 | PREMICATH | INTRAVASCULAR CATHETER | LJS | VYGON USA | 1261.203A | 23A005D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 MO | Male |