NUTRILINE
Report
- Report Number
- 2245270-2023-00021
- Event Type
- Malfunction
- Date Received
- March 28, 2023
- Date of Event
- March 21, 2023
- Report Date
- August 10, 2023
- Manufacturer
- VYGON USA
- Product Code
- LJS
- PMA / PMN Number
- K051690
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THERE WERE THREE OCCURRENCES WITHIN THIS COMPLAINT. THOSE OCCURRENCES WERE CAPTURED IN THE FOLLOWING MDRS: 2245270-2023-00019 2245270-2023-00020 2245270-2023-00021 THE COMPLAINT WAS FORWARDED TO OUR PARENT COMPANY IN GERMANY FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: WE RECEIVED THREE CATHETERS, TWO STYLETS, AND 3 Y-PIECES. THE FIRST CATHETER WAS CUT OFF AT 15 CM. THE STYLET WAS TORN OUT OF THE Y-PIECE. THE SECOND CATHETER RUPTURED AT 21,54 CM PROBABLY DUE TO THE CONCERTINAED CATHETER. THE STYLET SHOWED A KINK AND A CURLED END PROBABLY DUE TO THE ATTEMPT TO REMOVE IT FROM THE CATHETER WITH A TOOL AFTER IT SLIPPED OUT OF THE Y-PIECE. THE THIRD CATHETER WAS COMPLETE AND AIRTIGHT. NO STYLET WAS RETURNED. THE Y-PIECES RETURNED WITH THE THREE SAMPLES ALL SHOWED SIGNS OF SUFFICIENT GLUING AND STYLET CLAMPING. THE FOLLOWING INFORMATION IS PROVIDED IN THE PRODUCT IFU REGARDING STYLET REMOVAL, CAUTION: "IF THE 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 WAS PERFORMED, AND NO DEVIATIONS WERE FOUND. THE BATCHES COMPLIED WITH ITS SPECIFICATION AND WERE RELEASED. EACH CATHETER IS LEAK AND FLOW TESTED DURING PRODUCTION. THE TENSILE FORCE OF THE CATHETER COMPONENTS IS RANDOMLY CHECKED. INCOMING GOODS INSPECTIONS AND TWO 100% VISUAL TESTS AFTER PACKAGING ARE CARRIED OUT WITH NO EXCEPTIONS FOUND. WE RECEIVED 8 COMPLAINTS FOR BATCH 8178394, 3 COMPLAINTS FOR BATCH 8172410, AND 8 COMPLAINTS FOR BATCH 8171598, BUT NO FURTHER COMPLAINTS REGARDING A DETACHED STYLET ON CODE 4G07125203 WITHIN THE LAST THREE YEARS. THIS QUERY COVERS ALL COMPLAINTS THAT HAVE COME TO OUR ATTENTION WORLDWIDE. CORRECTIVE ACTION: NO FURTHER CORRECTIVE ACTION IS INITIATED BY QUALITY MANAGEMENT DUE TO THIS COMPLAINT, AS THERE ARE NO INDICATIONS OF A MANUFACTURING FAULT.
THERE WERE THREE OCCURRENCES WITHIN THIS COMPLAINT. THOSE OCCURRENCES WERE CAPTURED IN THE FOLLOWING MDRS: 2245270-2023-00019. 2245270-2023-00020. 2245270-2023-00021. THE MALFUNCTIONING DEVICES HAVE NOT YET BEEN RETURNED TO VYGON FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THEREFORE, THE RESULTS OF THIS INVESTIGATION ARE PENDING.
THERE WERE THREE OCCURRENCES WITHIN THIS COMPLAINT. THOSE OCCURRENCES WERE CAPTURED IN THE FOLLOWING MDRS: 2245270-2023-00019; 2245270-2023-00020; 2245270-2023-00021. THE MALFUNCTIONING DEVICES WERE SENT TO DECONTAMINATION SITE FOR FURTHER PROCESSING AND HAVE NOT BEEN RETURNED FOR EVALUATION, THEREFORE THE RESULTS OF THIS INVESTIGATION IS STILL PENDING.
THERE WERE THREE OCCURRENCES WITHIN THIS COMPLAINT. THOSE OCCURRENCES WERE CAPTURED IN THE FOLLOWING MDRS: 2245270-2023-00019; 2245270-2023-00020. THE MALFUNCTIONING DEVICES 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.
RN ABLE TO INSERT PICC LINE BUT HAD DIFFICULTY REMOVING STYLET FROM PICC LINE; STYLET FELT STICKY AND STUCK IN LINE. ATTEMPT #1 - PICC RN REQUIRED ASSISTANCE TO REMOVE STYLET OUT. PICC LINE REMOVED AND NOTED TO BE ACCORDION IN SHAPE. ATTEMPT #2 - PICC LINE TRIMMED AND RETHREADED AND SAME ISSUE OCCURRED. ATTEMPT #3 - NEW LOT NUMBER (22H009D), NEW PICC SITE AND SAME ISSUE OCCURRED.
RN ABLE TO INSERT PICC LINE BUT HAD DIFFICULTY REMOVING STYLET FROM PICC LINE; STYLET FELT STICKY AND STUCK IN LINE. ATTEMPT #1 - PICC RN REQUIRED ASSISTANCE TO REMOVE STYLET OUT. PICC LINE REMOVED AND NOTED TO BE ACCORDION IN SHAPE. ATTEMPT #2 - PICC LINE TRIMMED AND RETHREADED AND SAME ISSUE OCCURRED. ATTEMPT #3 - NEW LOT NUMBER (22H009D), NEW PICC SITE AND SAME ISSUE OCCURRED.
RN ABLE TO INSERT PICC LINE BUT HAD DIFFICULTY REMOVING STYLET FROM PICC LINE; STYLET FELT STICKY AND STUCK IN LINE. ATTEMPT #1 - PICC RN REQUIRED ASSISTANCE TO REMOVE STYLET OUT. PICC LINE REMOVED AND NOTED TO BE ACCORDION IN SHAPE. ATTEMPT #2 - PICC LINE TRIMMED AND RETHREADED AND SAME ISSUE OCCURRED. ATTEMPT #3 - NEW LOT NUMBER (22H009D), NEW PICC SITE AND SAME ISSUE OCCURRED.
RN ABLE TO INSERT PICC LINE BUT HAD DIFFICULTY REMOVING STYLET FROM PICC LINE; STYLET FELT STICKY AND STUCK IN LINE. ATTEMPT #1 - PICC RN REQUIRED ASSISTANCE TO REMOVE STYLET OUT. PICC LINE REMOVED AND NOTED TO BE ACCORDION IN SHAPE. ATTEMPT #2 - PICC LINE TRIMMED AND RETHREADED AND SAME ISSUE OCCURRED. ATTEMPT #3 - NEW LOT NUMBER (22H009D), NEW PICC SITE AND SAME ISSUE OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10112 | NUTRILINE | LONG-TERM INTRAVASCULAR CATHETER | LJS | VYGON USA | 1252.030G | 22I006D AND 22H009D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |