NUNTRILINE
Report
- Report Number
- 2245270-2022-00005
- Event Type
- Malfunction
- Date Received
- February 9, 2022
- Date of Event
- January 25, 2022
- Report Date
- April 7, 2022
- Manufacturer
- VYGON USA
- Product Code
- LJS
- PMA / PMN Number
- K051690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PLEASE SEE MDR 2245270-2022-00006 FOR DATA FOR AN ADDITIONAL OCCURENCE OF THIS MALFUCTION WITH THIS CUSTOMER. WE RECEIVED TWO CATHETERS AS FAULTY SAMPLES. FLUSHING SAMPLE #1 DOESN'T RESULT IN A FLOW AS IT IS SEVERE OCCLUDED. FLUSHING SAMPLE #2 SHOWS A LEAKAGE RIGHT BELOW THE WING. MICROSCOPIC EXAMINATION SHOWS RESPECTIVELY THAT THE CATHETER TUBES ARE PARTLY TORN OUT AT THE JUNCTION. THE SURFACES OF THE BREAKAGE AREAS ARE ROUGH AND UNEVEN WHICH IS A TYPICAL SIGN FOR A TENSILE FRACTURE. WE WERE INFORMED THAT THE CUSTOMER USED CHLORHEXIDINE, BUT IT WASN'T MENTIONED IF THE DISINFECTANT WAS ALCOHOL- OR WATER-BASED. 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." MOREOVER, WE HAVE A WARNING LEAFLET IN EACH BLISTER WHICH DECLARES: "NEVER USE ORGANIC SOLVENTS SUCH AS ALCOHOL DIRECTLY ON THE CATHETER, IT MAY WEAKEN THE MATERIAL. IF AN ALCOHOL-BASED DISINFECTANT IS USED ON THE INSERTION SKIN AREA, IT MUST DRY COMPLETELY BEFORE EXPOSING THE CATHETER TO ANY MECHANICAL STRESS. FURTHERMORE, FROM PREVIOUS COMPLAINTS WE LEARN OF VARIOUS POSSIBLE CAUSES OF A TENSILE FRACTURE: 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 RESULTING 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. A REVIEW OF THE BATCH HISTORY RECORDS WAS PERFORMED, AND NO DEVIATIONS WERE FOUND. EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE FORCE OF THE CATHETER COMPONENTS IS RANDOMLY CHECKED. VISUAL TESTS AND INCOMING GOODS INSPECTIONS ARE CARRIED OUT WITH NO EXCEPTIONS FOUND. THERE ARE THREE ADDITIONAL COMPLAINTS FOR BATCH 8131566, FIVE FURTHER COMPLAINTS FOR BATCH 8134052 AND, FIVE FURTHER COMPLAINTS REGARDING A LEAKING CATHETER AT THE JUNCTION ON DEVICE CODE 4G07125203 WITHIN THE LAST THREE YEARS. NO FURTHER CORRECTIVE ACTION INITIATED BY QUALITY MANAGEMENT AS THE CATHETER WORKED WELL FOR ONE MONTH AND THERE ARE NO INDICATIONS OF A MANUFACTURING FAULT. CORRECTIVE ACTION: NO FURTHER CORRECTIVE ACTION INITIATED BY QUALITY MANAGEMENT DUE TO THIS COMPLAINT, AS THE CATHETER WORKED WELL FOR ONE MONTH AND THERE ARE NO INDICATIONS OF A MANUFACTURING FAULT.
PLEASE SEE MDR 2245270-2022-00006 FOR DATA FOR AN ADDITIONAL OCCURENCE OF THIS MALFUNCTION WITH THIS CUSTOMER. THE MALFUNCTIONING DEVICE WILL BE RETURNED TO VYGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.
TWO PATIENTS IN THE UNIT WITH BROKEN/LEAKING PICC LINES. BOTH LINES LEAKING AT HUB WHERE HUB CONNECTS TO THE LINE
TWO PATIENTS IN THE UNIT WITH BROKEN/LEAKING PICC LINES. BOTH LINES LEAKING AT HUB WHERE HUB CONNECTS TO THE LINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59700 | NUNTRILINE | LONG-TERM-INTRAVASCULAR CATHETER | LJS | VYGON USA | 1252.030G | 21D011D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |