BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Report
- Report Number
- 1710034-2022-00790
- Event Type
- Malfunction
- Date Received
- December 12, 2022
- Date of Event
- November 15, 2022
- Report Date
- February 21, 2023
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 50382903814348
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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: 03-FEB-2023. H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 570 20GX0.16IN INSYTE AUTOGUARD DEVICES FROM LOT NUMBER 2160587. A GROSS VISUAL INSPECTION SHOWS THAT THE UNITS ARE SEALED IN THEIR PACKAGING AND DO NOT HAVE APPARENT PHYSICAL DAMAGED. PER THE REPORT NEEDLE RETRACTION FAILURE WAS EXPERIENCED WHILE USING THE UNITS. TO FURTHER INVESTIGATE, A SAMPLING OF 20 UNITS WERE TESTED BY ENGAGING THE SAFETY BUTTON. OF THE SAMPLED UNITS, 2 UNITS FAILED RETRACTION THEREFORE CONFIRMING YOUR REPORTED ISSUE. THESE UNITS WERE THEN MICROSCOPICALLY INSPECTED WHERE EXCESSIVE ADHESIVE WAS FOUND BETWEEN THE SAFETY BUTTON AND THE GRIP. THIS MAY OCCUR AT THE ADHESIVE DISPENSE PROCESS DUE TO STATION MISALIGNMENT, PART MISALIGNMENT OR ADHESIVE BUILDUP ON THE NOZZLE. PER THE QUALITY CONTROL PLAN, INSPECTIONS FOR NEEDLE RETRACTION AND EXCESSIVE ADHESIVE ARE PERFORMED PERIODICALLY DURING THE MANUFACTURING PROCESS TO MITIGATE THE OCCURRENCE OF THIS DEFECT. PREVENTATIVE MAINTENANCE (PM¿S) IS PERFORMED TO MAINTAIN AND ENSURE PROPER FUNCTIONING OF EQUIPMENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE. H3 OTHER TEXT : SEE H10.
SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H10.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 IS NOT RETRACTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTIPLE COMPLAINTS OF NEEDLE NOT RETRACTING. ADDITIONAL INFORMATION RECEIVED 17-NOV-2022 NEEDLE IS NOT RETRACTING SO THIS MAKES OBTAINING A SAMPLE DIFFICULT.
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER IS NOT RETRACTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTIPLE COMPLAINTS OF NEEDLE NOT RETRACTING. ADDITIONAL INFORMATION RECEIVED 17-NOV-2022 NEEDLE IS NOT RETRACTING SO THIS MAKES OBTAINING A SAMPLE DIFFICULT.
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER IS NOT RETRACTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MULTIPLE COMPLAINTS OF NEEDLE NOT RETRACTING. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022. NEEDLE IS NOT RETRACTING SO THIS MAKES OBTAINING A SAMPLE DIFFICULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2130259 | BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 381434 | 2160587 | 50382903814348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |