BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Report
- Report Number
- 1710034-2023-00878
- Event Type
- Malfunction
- Date Received
- August 7, 2023
- Date of Event
- July 20, 2023
- Report Date
- August 29, 2023
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903814237
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, 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, RETURNED TO MANUFACTURER ON: 03-AUG-2023. H6: INVESTIGATION SUMMARY: BD RECEIVED TWO UNSEALED 22 GAUGE INSYTE AUTOGUARD UNITS FROM LOTS 2235211 AND 3033949 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOTS AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS AND OBSERVED THAT BOTH UNITS WERE ALREADY RETRACTED. NEXT, THE ENGINEER RESET THE DEVICES AND PLACED THE NEEDLES BACK INTO THEIR ORIGINAL POSITIONS BEFORE INITIATING RETRACTION. BOTH UNITS RETRACTED SUCCESSFULLY. HOWEVER, UPON FURTHER INSPECTION, THE ENGINEER DISCOVERED THAT ONE OF THE UNITS HAD SLIGHT DAMAGE TO THE BARREL/GRIP INTERFACE. THIS DAMAGE COULD AFFECT THE NEEDLE'S ABILITY TO RETRACT. THERE APPEARED TO BE ROOM WITHIN THE BARREL FOR THE NEEDLE HUB TO BYPASS THE DAMAGED EDGE, BUT IF THE NEEDLE HUB AND TRAJECTORY OF RETRACTION WAS ALIGNED, IT WOULD CATCH ON THE DAMAGE AND PREVENT RETRACTION. THE ENGINEER ATTEMPTED TO RETRACT THE DEVICE AND THIS TIME IT FAILED TO RETRACT COMPLETELY VERIFYING THIS ISSUE. HOWEVER, THERE APPEARED TO BE NO ISSUES WITH THE SECOND DEVICE. IT RETRACTED SUCCESSFULLY AND HAD NO DAMAGE FOUND. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT THAT OCCURRED DUE TO DAMAGE TO THE BARREL. THIS TYPE OF DAMAGE CAN OCCUR IF THERE WAS A MISALIGNMENT BETWEEN THE BARREL AND THE MANUFACTURING EQUIPMENT DURING ASSEMBLY.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2235211 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2025 H.4. DEVICE MANUFACTURE DATE: 23-AUG-2022 D.4. MEDICAL DEVICE LOT #: 3033949 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2026 H.4. DEVICE MANUFACTURE DATE: 09-FEB-2023 H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE ONLY RETRACTED HALFWAY AFTER HITTING THE SAFETY BUTTON. THIS OCCURRED ONCE EACH IN LOTS 2235211 AND 3033949. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE JUST HAD TWO MORE COME THROUGH WITH ISSUES... AFTER ATTEMPTING START ON PATIENT HIT BUTTON TO RETRACT NEEDLE AND THE NEEDLE ONLY RETRACTED HALFWAY AND NEVER ENTERED THE FULL SAFETY."
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE ONLY RETRACTED HALFWAY AFTER HITTING THE SAFETY BUTTON. THIS OCCURRED ONCE EACH IN LOTS 2235211 AND 3033949. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE JUST HAD TWO MORE COME THROUGH WITH ISSUES... AFTER ATTEMPTING START ON PATIENT HIT BUTTON TO RETRACT NEEDLE AND THE NEEDLE ONLY RETRACTED HALFWAY AND NEVER ENTERED THE FULL SAFETY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1158683 | BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | SEE H10 | 00382903814237 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |