PREMICATH
Report
- Report Number
- 2245270-2023-00016
- Event Type
- Malfunction
- Date Received
- March 9, 2023
- Date of Event
- March 2, 2023
- Report Date
- April 28, 2023
- Manufacturer
- VYGON USA
- Product Code
- LJS
- PMA / PMN Number
- K041468
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE SAMPLE IS STILL IN DECONTAMINATION PROCESS AND HAS NOT BEEN RETURNED FOR EVALUATION. THE RESULTS OF THIS INVESTIGATION IS STILL PENDING.
THE COMPLAINT WAS FORWARDED TO OUR PARENT COMPANY IN GERMANY FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: WE RECEIVED THE Y-PIECE AND THE SEPARATED STYLET AS SAMPLES. MICROSCOPICAL EXAMINATION OF THE Y-PIECE SHOWED THE TYPICAL CLAMPING TRACE OF THE STYLET. THIS INDICATES THAT THE STYLET WAS SUFFICIENTLY CLAMPED. THE USER OBVIOUSLY HAD STYLET REMOVAL ISSUES. THE FOLLOWING INFORMATION IS PROVIDED IN THE PRODUCT IFU REGARDING STYLET REMOVAL, "IF 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". ADDITIONAL TESTING HAS SHOWN THAT A BOLUS OF DILUTED LIPID SOLUTION HELPS TO WITHDRAW THE STYLET EASILY. A REVIEW OF THE BATCH HISTORY RECORDS FOR 8138684 AND 8091216 WAS PERFORMED, AND NO DEVIATIONS WERE FOUND. THE BATCH COMPLIED TO ITS SPECIFICATION AND WAS RELEASED. EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE FORCE AND DIMENSIONS OF CATHETER COMPONENTS ARE RANDOMLY CHECKED. INCOMING GOODS INSPECTIONS AND VISUAL TESTS AFTER PACKAGING ARE CARRIED OUT WITH NO EXCEPTIONS FOUND. THERE WERE TWO ADDITIONAL COMPLAINTS FOR BATCH 8138684 AND FOUR ADDITIONAL COMPLAINTS FOR BATCH 8091216. THERE WERE NO ADDITIONAL COMPLAINTS ABOUT A SNAPPED STYLET IN CODE 4G07126112 WITHIN THE LAST THREE YEARS. CORRECTIVE ACTION: NO FURTHER CORRECTIVE ACTION INITIATED BY QUALITY MANAGEMENT DUE TO THIS COMPLAINT, AS THERE ARE NO INDICATIONS OF A MANUFACTURING FAULT.
THE FAILED DEVICE WILL BE RETURNED TO VYGON FOR EVALUATION AND COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING, AND WILL BE COMMUNICATED TO FDA WITHIN 30 DAYS OF ITS CONCLUSION.
THE CATHETER WAS PRIMED WITH STERILE SALINE AND PLACED INTO THE PATIENT. WHEN THE CLINICIAN WENT TO REMOVE THE STYLET THE STYLET BECAME DIFFICULT TO REMOVE. THE CLINICIAN APPLIED MORE FORCE TO REMOVE THE STYLET RESULTING IN THE PLASTIC HUB DETACHING FROM THE STYLET. THE CLINICIAN GRABBED THE STYLET AND SLOWLY REMOVED THE STYLET FROM THE CATHETER.
THE CATHETER WAS PRIMED WITH STERILE SALINE AND PLACED INTO THE PATIENT. WHEN THE CLINICIAN WENT TO REMOVE THE STYLET THE STYLET BECAME DIFFICULT TO REMOVE. THE CLINICIAN APPLIED MORE FORCE TO REMOVE THE STYLET RESULTING IN THE PLASTIC HUB DETACHING FROM THE STYLET. THE CLINICIAN GRABBED THE STYLET AND SLOWLY REMOVED THE STYLET FROM THE CATHETER.
THE CATHETER WAS PRIMED WITH STERILE SALINE AND PLACED INTO THE PATIENT. WHEN THE CLINICIAN WENT TO REMOVE THE STYLET THE STYLET BECAME DIFFICULT TO REMOVE. THE CLINICIAN APPLIED MORE FORCE TO REMOVE THE STYLET RESULTING IN THE PLASTIC HUB DETACHING FROM THE STYLET. THE CLINICIAN GRABBED THE STYLET AND SLOWLY REMOVED THE STYLET FROM THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1777231 | PREMICATH | LONG TERM INTRAVASCULAR CATHETER | LJS | VYGON USA | 1261.306A | 22H004D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |