PREMICATH
Report
- Report Number
- 2245270-2023-00062
- Event Type
- Malfunction
- Date Received
- September 25, 2023
- Date of Event
- August 21, 2023
- Report Date
- January 3, 2024
- Manufacturer
- VYGON USA
- Product Code
- LJS
- PMA / PMN Number
- K041468
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE FAILED SAMPLE HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER FOR INVESTIGATION. THEREFORE, THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING.
WE RECEIVED ONE USED CATHETER AS A SAMPLE. WE RECEIVED THE CATHETER CONNECTED TO A NEEDLE-FREE CONNECTION SYSTEM. FLUSHING DISPLAYED A LEAKAGE AT THE JUNCTION BETWEEN THE CATHETER TUBE AND THE EXTENSION LINE. THE SURFACE OF THE FRACTURE PLANE IS ROUGH, WHICH IS A TYPICAL SIGN OF A HIGH TENSILE LOAD APPLIED TO THE CATHETER. VARIOUS POSSIBLE CAUSES CAN LEAD TO CATHETER LEAKAGE/TENSILE FRACTURE: DRESSING CHANGE: IN SOME INSTANCES, THE CATHETER CAN BECOME ADHERED TO THE DRESSING AND ADDITIONAL PULLING IS USED TO FREE IT, PLACING STRESS ON THE LINE WHICH COULD RESULT IN A TENSILE FRACTURE. ROUTINE CARE: WHEN LIFTING THE BABY TO CHANGE BEDDING. MOVEMENT: THE BABY THEMSELVES CATCHING THE LINE, NORMALLY WITH A FOOT, DURING MOVEMENT. USE OF ALCOHOL-BASED DISINFECTANT. THERE IS A STATEMENT IN OUR PRODUCT'S IFU: "BE AWARE THAT ORGANIC SOLVENTS SUCH AS ALCOHOL OR ACETONE MAY INTERACT WITH CATHETER MATERIAL AND WEAKEN IT." AND "AVOID ANY CONTACT OF THE CATHETER TUBING TO ALCOHOL-CONTAINING DISINFECTANTS. THIS MAY IRREVERSIBLY DAMAGE THE CATHETER." A REVIEW OF THE BATCH HISTORY RECORDS WAS PERFORMED FOR 8172403, 8172417, 8172418, AND NO DEVIATIONS WERE FOUND. EACH CATHETER IS FLOW AND LEAK-TESTED DURING PRODUCTION. THE TENSILE FORCE OF THE CATHETER COMPONENTS IS RANDOMLY CHECKED. INCOMING GOODS INSPECTIONS AND TWO 100 % VISUAL TESTS AFTER PACKAGING ARE CONDUCTED WITH NO EXEMPTIONS FOUND. THE BATCHES COMPLIED WITH ITS SPECIFICATIONS AND WERE RELEASED. THERE ARE NO FURTHER COMPLAINTS FOR BATCH 8172403, NO FURTHER COMPLAINTS FOR BATCH 8172417, ONE FURTHER COMPLAINT FOR BATCH 8172418, AND FOUR FURTHER COMPLAINTS REGARDING A LEAKING CATHETER ON CODE 4G07126104 WITHIN THE LAST THREE YEARS. THIS QUERY RELATES TO ALL COMPLAINTS THAT HAVE COME TO OUR ATTENTION WORLDWIDE. CORRECTIVE ACTION: AS THE CATHETER WORKED WELL FOR 12 DAYS BEFORE THE LEAKAGE OCCURRED, WE DO NOT BELIEVE THIS DEFECT IS MANUFACTURING RELATED. ANY MANUFACTURING PROBLEMS THAT WOULD LEAD TO A LEAK WOULD BE DETECTED BY THE USER WHEN INITIALLY FLUSHING THE CATHETER. THEREFORE, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT AT THIS TIME.
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.
NURSE NOTICED THAT THERE WAS FLUID POOLING UNDERNEATH THE DRESSING. THEY ENDED UP REMOVING THE PICC FROM THE PATIENT PER MD ORDER. UPON FLUSHING THE CATHETER, THEY CAN SEE FLUID LEAKING FROM THE HUB.
NURSE NOTICED THAT THERE WAS FLUID POOLING UNDERNEATH THE DRESSING. THEY ENDED UP REMOVING THE PICC FROM THE PATIENT PER MD ORDER. UPON FLUSHING THE CATHETER, THEY CAN SEE FLUID LEAKING FROM THE HUB.
NURSE NOTICED THAT THERE WAS FLUID POOLING UNDERNEATH THE DRESSING. THEY ENDED UP REMOVING THE PICC FROM THE PATIENT PER MD ORDER. UPON FLUSHING THE CATHETER, THEY CAN SEE FLUID LEAKING FROM THE HUB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1421833 | PREMICATH | LONG-TERM INTRAVASCULAR CATHETER | LJS | VYGON USA | 1261.203A | 22D012D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 DA | Female |