NUTRILINE
Report
- Report Number
- 2245270-2021-00126
- Event Type
- Malfunction
- Date Received
- December 17, 2021
- Date of Event
- November 11, 2021
- Report Date
- February 24, 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
THIS MALFUNCTION WAS FIRST REPORTED TO FDA BY THE CUSTOMER VIA MEDWATCH (B)(4). THIS COMPLAINT CANNOT BE CLASSIFIED AS NO FAULTY SAMPLE IS AVAILABLE. WE DID NOT RECEIVE THE DEFECTIVE SAMPLE FOR EVALUATION. ACCORDING TO THE COMPLAINT FORM, DURING DRESSING CHANGE, THE CATHETER WAS FOUND TO BE LEAKING AROUND THE SITE. 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. THEREFORE, IT IS NOT LIKELY THAT THE LEAK REPORTED WAS A RESULT OF A MANUFACTURING DEFECT. THERE ARE TWO FURTHER COMPLAINTS FOR BATCH 8106773, AND NO OTHER COMPLAINTS FOR BATCH 8138676. NO FURTHER CORRECTIVE ACTION INITIATED BY QUALITY MANAGEMENT AS DUE TO THE MISSING SAMPLE, NO ROOT CAUSE ANALYSIS CAN BE MADE. CORRECTIVE ACTION: DUE TO THE MISSING SAMPLE, THE CAUSE OF THIS ISSUE COULD NOT BE DETERMINED. THEREFORE, NO CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME. THIS FAILURE WILL BE MONITORED FOR FUTURE ACTIONS.
THIS MALFUNCTION WAS FIRST REPORTED TO FDA BY THE CUSTOMER VIA MEDWATCH (B)(4). ALTHOUGH THE MALFUNCTIONING DEVICE WAS NOT RETURNED TO VYGON THE DETAILS OF THE MALFUNCTION WERE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO FDA WITH THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.
NURSE (RN) NOTED THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) SITE DRESSING WAS QUESTIONABLY WET. PICC RN CALLED TO BEDSIDE TO ASSESS SITE. PICC RN ASSURED RN PICC SITE LOOKED OKAY AND DID NOT THINK THE SITE WAS WET. PATIENT'S RN STILL CONCERNED ABOUT SITE DUE TO PATIENT BEHAVIOR SUGGESTING THERE MAY BE A CONCERN. RN CALLED NEONATAL NURSE (NNP) AND REQUESTED TO ASSESS SITE. NNP CAME TO BEDSIDE AND FLUSHED THE SITE AND STATED THAT IS FLUSHED OKAY. NNP WAS REDRESSING THE SITE WHEN SHE THEN NOTICED SOME LEAKING AROUND THE SITE. WHEN THE NNP FLUSHED THE SITE AGAIN, THE FLUSH SQUIRT OUT OF THE SIDE OF THE PICC, SUGGESTING SOMETHING WAS WRONG WITH THE PICC. PICC DISCONTINUED. PIV PLACED TO MAINTAIN FLUIDS AND DROPS PER MINUTE (GTTS) FOR INFANT UNTIL NNP COULD RETURN TO PLACE ANOTHER PICC.
NURSE (RN) NOTED THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) SITE DRESSING WAS QUESTIONABLY WET. PICC RN CALLED TO BEDSIDE TO ASSESS SITE. PICC RN ASSURED RN PICC SITE LOOKED OKAY AND DID NOT THINK THE SITE WAS WET. PATIENT'S RN STILL CONCERNED ABOUT SITE DUE TO PATIENT BEHAVIOR SUGGESTING THERE MAY BE A CONCERN. RN CALLED NEONATAL NURSE (NNP) AND REQUESTED TO ASSESS SITE. NNP CAME TO BEDSIDE AND FLUSHED THE SITE AND STATED THAT IS FLUSHED OKAY. NNP WAS REDRESSING THE SITE WHEN SHE THEN NOTICED SOME LEAKING AROUND THE SITE. WHEN THE NNP FLUSHED THE SITE AGAIN, THE FLUSH SQUIRT OUT OF THE SIDE OF THE PICC, SUGGESTING SOMETHING WAS WRONG WITH THE PICC. PICC DISCONTINUED. PIV PLACED TO MAINTAIN FLUIDS AND DROPS PER MINUTE (GTTS) FOR INFANT UNTIL NNP COULD RETURN TO PLACE ANOTHER PICC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1925908 | NUTRILINE | LONG-TERM INTRAVASCULAR CATHETER | LJS | VYGON USA | 1252.31G | 21E018D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |