BD INSYTE-N AUTOGUARD WINGED
Report
- Report Number
- 1710034-2023-01441
- Event Type
- Malfunction
- Date Received
- December 12, 2023
- Date of Event
- November 21, 2023
- Report Date
- April 12, 2024
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903826124
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CLARIFYING INFORMATION WAS RECEIVED REGARDING THE MATERIAL AND LOT NUMBERS. VERIFICATION PERFORMANCES DONE AND THE COMPLAINT HAS BEEN UPDATED. INFORMATION REFLECTED IN TAB D AND H.
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D. BATCH NUMBER WAS PROVIDED AS 3002679. IT WAS NOT FOUND FOR MATERIAL NUMBER 381511.
INVESTIGATION RESULTS: RECEIVED ONE UNIT OF A 24GX0.75IN INSYTE AUTOGUARD DEVICE FROM LOT 3002679 FOR THE INVESTIGATION OF THIS COMPLAINT. A GROSS VISUAL INSPECTION SHOWS THAT THE UNIT HAS BEEN REMOVED FROM THE PACKAGING. THE NEEDLE HAS BEEN RETRACTED IN THE BARREL AND THE NEEDLE COVER WAS NOT PROVIDED. PER THE CUSTOMER¿S VERBATIM, THERE WAS A HOLE ON THE CATHETER REQUIRING THEM TO CHANGE THE UNIT DURING USE. THEY THEREFORE RETURNED THE SAMPLE FOR INVESTIGATION. INVESTIGATION WAS PERFORMED BY INSPECTING THE CATHETER UNDER THE MICROSCOPE. IT WAS OBSERVED THAT THE CATHETER HAD WHAT APPEARED TO BE 2 PERFORATIONS IN THE TUBING NEAR THE TIP. THE TWO PUNCTURES WERE POTENTIALLY CAUSED BY DOUBLE CANNULATION OF THE DEVICE DURING THE INSERTION PROCESS. EVEN THOUGH THE DEFECT OF SPEAR THROUGH COULD ALSO ORIGINATE AS PART OF THE MANUFACTURING PROCESS AS INDICATED BY THE PEURA REVIEW, IT IS UNLIKELY THAT A DOUBLE CANNULATION OCCURS DURING MANUFACTURING. 100% VISUAL INSPECTIONS ARE UTILIZED TO REJECT DEFECTIVE UNITS DURING MANUFACTURING. IT WAS REPORTED THAT THE DEVICE WAS USED BY THE CUSTOMER BEFORE THE HOLES WERE NOTED; THEREFORE, IT IS POSSIBLE THAT THE DAMAGE ORIGINATED DUE TO IMPROPER USE EITHER DURING TIP ADHESION BREAK OR DURING THE VENIPUNCTURE ATTEMPT IN THE CLINICIAN ENVIRONMENT. THE INSTRUCTIONS FOR USE (IFU) WARN THAT IF THE NEEDLE IS PARTIALLY OR COMPLETELY WITHDRAWN FROM THE CATHETER TUBING DURING INSERTION, DO NOT RE-INSERT THE NEEDLE INTO THE CATHETER TUBING AS DAMAGE MAY OCCUR. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INVESTIGATION CONCLUSION(S): THE COMPLAINT OF ¿CATHETER DEFECTIVE/DAMAGED¿ WAS CONFIRMED. PROBABLE ROOT CAUSE CONCLUSION(S): UNDETERMINED.
NA.
IT WAS REPORTED THAT BD INSYTE-N AUTOGUARD WINGED HAD A HOLE IN THE CATHETER THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DAMAGED IV CATH, HOLE INSIDE OF THE 24G IV CATHETER, HAD TO CHANGE CATHETERS WHICH REQUIRED THE PATIENT TO BE STUCK AGAIN. EXTRA STICK HAD TO BE DONE DUE TO THE DAMAGED CATH HAVING A HOLE." "EXTRA STICK HAD TO BE DONE DUE TO THE DAMAGED CATH HAVING A HOLE."
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1525685 | BD INSYTE-N AUTOGUARD WINGED | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 3002679 | 00382903826124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |