BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16"
Report
- Report Number
- 1710034-2023-00854
- Event Type
- Injury
- Date Received
- August 1, 2023
- Date of Event
- July 7, 2023
- Report Date
- August 23, 2023
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903814343
- PMA / PMN Number
- K201075
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 14-JUL-2023 . H6: INVESTIGATION SUMMARY BD RECEIVED A USED 20 GAUGE INSYTE AUTOGUARD DEVICE FROM LOT AN UNKNOWN LOT FOR EVALUATION. EVEN THOUGH THE OF THE RETURNED UNIT WAS UNKNOWN IT WAS REPORTED THAT THIS DEFECT WAS OCCURRING WITH MULTIPLE POSSIBLE LOTS, 3096288, 3102579, 3055278, 3080736, AND 3017206. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON EACH OF THESE LOTS AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED THAT THE CATHETER TUBING WAS MISSING FROM THE UNIT. THE ENGINEER DISSECTED THE UNIT AND INSPECTED THE COMPONENTS TO SEE IF THERE WERE ANY POSSIBLE ISSUES. IT WAS FOUND THAT THE CATHETER TUBING WAS COMPLETELY MISSING. NO PORTIONS OF THE CATHETER TUBING WAS PRESENT IN THE RETURNED UNIT. THIS INDICATED THAT THE CATHETER TUBING BECAME COMPLETELY SEPARATED FROM THE DEVICE'S WEDGE AND CATHETER ADAPTER. THEREFORE, BASED OFF THE PERFORMED INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT THAT OCCURRED DURING THE ASSEMBLY PROCESS.
D.4 DEVICE EXPIRATION DATE: UNKNOWN. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16" CATHETER SEPARATED FROM HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN IV CATHETER WAS REPORTED TO BE DISCONNECTED FROM THE HUB OF THE IV. "UPON DISCOVERY OF THE CATHETER BEING MISSING, THE ED PHYSICIAN DID AN EXTREMITY ULTRASOUND AT THE POINT OF CARE AND FOUND NO EVIDENCE OF THE CATHETER. THE PATIENT HAD IR CONSULTED FOR VENOGRAM AT 9AM YESTERDAY MORNING." I DID WANT TO SHARE THAT THE IV HUB WAS INDEED FOUND RETAINED IN THE PATIENT, NOT FAR FROM HER ORIGINAL IV SITE. IT WAS REMOVED VIA CUTDOWN.
IT WAS REPORTED THAT THE BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16" CATHETER SEPARATED FROM HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN IV CATHETER WAS REPORTED TO BE DISCONNECTED FROM THE HUB OF THE IV. "UPON DISCOVERY OF THE CATHETER BEING MISSING, THE ED PHYSICIAN DID AN EXTREMITY ULTRASOUND AT THE POINT OF CARE AND FOUND NO EVIDENCE OF THE CATHETER. THE PATIENT HAD IR CONSULTED FOR VENOGRAM AT 9AM YESTERDAY MORNING." I DID WANT TO SHARE THAT THE IV HUB WAS INDEED FOUND RETAINED IN THE PATIENT, NOT FAR FROM HER ORIGINAL IV SITE. IT WAS REMOVED VIA CUTDOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1555258 | BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16" | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | UNKNOWN | 00382903814343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |