PREMICATH
Report
- Report Number
- 2245270-2025-00080
- Event Type
- Malfunction
- Date Received
- July 29, 2025
- Date of Event
- February 19, 2025
- Report Date
- September 15, 2025
- Manufacturer
- VYGON USA
- Product Code
- LJS
- PMA / PMN Number
- K041468
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE INVESTIGATION SUMMARY IS AS FOLLOWS: WE RECEIVED THE CATHETER AS FAULTY SAMPLE. A NON-VYGON GERMANY GMBH NEEDLE-FREE DEVICE WAS CONNECTED TO THE CATHETER'S LL HUB, AND THE CATHETER TUBE WAS SHORTENED AT THE 10 CM MARKING. THE ATTEMPT TO FLUSH THE CATHETER WITH WATER WAS SUCCESSFUL, AND LEAKAGE WAS DETECTED AT THE JUNCTION BETWEEN THE CATHETER TUBE AND THE EXTENSION LINE. MICROSCOPIC EXAMINATION REVEALED A LARGE TEAR/HOLE WITH A VERY ROUGH, JAGGED FRACTURE SURFACE AND SIGNS OF STRESS WHITENING, INDICATING EXPOSURE TO EXCESSIVE TENSILE FORCE. IN GENERAL, THERE ARE VARIOUS EVENTS THAT CAN LEAD TO A LEAKING CATHETER: 1. 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. - FOR BABIES, ROUTINE CARE (WHEN LIFTING THE BABY TO CHANGE THE BEDDING) AND MOVEMENT OF THE BABY ITSELF COULD RESULT IN A TENSILE FRACTURE. 2. MECHANICAL DAMAGE BY A SHARP INSTRUMENT (FOR EXAMPLE SCISSORS, TOOTHED FORCEPS OR SCALPEL) DURING DRESSING CHANGE. 3. ALCOHOL-BASED DISINFECTANT. CONCERNING THIS, THERE ARE SOME WARNINGS IN THE 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. THE CUSTOMER STATED IN THE PIR THAT AN ALCOHOL-BASED DISINFECTANT WAS USED. IN ADDITION, A MANUFACTURING DEFECT CAN BE RULED OUT, AS EACH CATHETER UNDERGOES FLOW AND LEAK TESTING DURING PRODUCTION. FURTHERMORE, ACCORDING TO THE CUSTOMER, THE CATHETER FUNCTIONED WITHOUT LEAKAGE FOR EIGHT DAYS, AND AN ALCOHOL-BASED DISINFECTANT WAS USED. A REVIEW OF THE COMPONENT BATCH HISTORY RECORDS; NO DEVIATIONS WERE FOUND. THE BATCH COMPLIED WITH ITS SPECIFICATION AND WAS RELEASED ACCORDINGLY. EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE FORCE AND DIMENSIONS OF CATHETER AND SET COMPONENTS ARE RANDOMLY CHECKED AS PART OF QUALITY CONTROL PROCESS. A TWO-YEAR REVIEW OF VYGON USA'S COMPLAINT DATA IDENTIFIED SIX ADDITIONAL COMPLAINTS RELATED TO LEAKING CATHETERS FROM LOT 23F014D. OF THESE, THREE COULD NOT BE CONFIRMED DUE TO MISSING SAMPLES, WHILE THE REMAINING THREE WERE ATTRIBUTED TO THE APPLICATION OF EXCESSIVE TENSILE FORCE AND THE USE OF ALCOHOL-BASED DISINFECTANTS, RATHER THAN A MANUFACTURING ISSUE. CORRECTIVE ACTION: AS EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION, AND THE CATHETER WORKED WELL FOR 8 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.
THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE REPORTED TO THE FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA A FOLLOW-UP MDR.
DRESSING LIFTING, 0.5CM OF CATH DISLODGED, SORBAVIEW DRESSING. NEW LINE WAS PLACED.
DRESSING LIFTING, 0.5CM OF CATH DISLODGED, SORBAVIEW DRESSING. NEW LINE WAS PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1266473 | PREMICATH | INTRAVASCULAR CATHETER | LJS | VYGON USA | 1261.203A | 23F014D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |