BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16"
Report
- Report Number
- 1710034-2023-00078
- Event Type
- Malfunction
- Date Received
- February 8, 2023
- Date of Event
- January 13, 2023
- Report Date
- August 21, 2023
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903814343
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: H6: IMDRF ANNEX B GRID: B01, B03, B14. H6: IMDRF ANNEX C GRID: C13. H6: IMDRF ANNEX D GRID: D03. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED FIVE SEALED 20G X 1.16IN. INSYTE AUTOGUARD UNITS FROM LOT NUMBER 2160587. THE UNITS WERE VISUALLY INSPECTED, AND NO DAMAGE OR DEFECTS WERE IDENTIFIED TO THE COMPONENTS. ALL UNITS WERE FUNCTIONALLY TESTED FOR NEEDLE RETRACTION AND ALL UNITS SUCCESSFULLY RETRACTED WITHOUT ISSUE. THESE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN YOUR REPORT. IN ADDITION, AFTER THE INITIAL INVESTIGATION, FIVE ADDITIONAL SAMPLES WERE RECEIVED FOR INVESTIGATION. WE RECEIVED TWO OPENED AND THREE SEALED 20G X 1.16IN. INSYTE AUTOGUARD UNITS FROM LOT NUMBER 2160587. THE UNITS WERE VISUALLY INSPECTED, AND NO DAMAGE OR DEFECTS WERE IDENTIFIED TO THE COMPONENTS. THE SEALED UNITS WERE FUNCTIONALLY TESTED FOR NEEDLE RETRACTION AND ALL THREE SUCCESSFULLY RETRACTED WITHOUT RESISTANCE. OF THE TWO OPENED UNITS (UNITS 1 & 2) UNIT 1 WAS RETURNED WITH A RETRACTED NEEDLE ASSEMBLY. THIS UNIT WAS MICROSCOPICALLY INSPECTED FOR ANY EVIDENCE THAT WOULD INDICATE THAT RETRACTION FAILURE HAD OCCURRED (E.G., ADHESIVE RESIDUE). NO EVIDENCE OF RETRACTION FAILURE WAS IDENTIFIED. UNIT 1 WAS ALSO UN-RETRACTED AND TESTED FOR NEEDLE RETRACTION. THE UNIT RETRACTED SUCCESSFULLY WITHOUT RESISTANCE. FINALLY, UNIT 2 WAS FUNCTIONALLY TESTED FOR NEEDLE RETRACTION. THE UNIT WAS UNABLE TO BE RETRACTED AS THE BUTTON WAS UNABLE TO BE PRESSED. FURTHER INSPECTION UNDER A MICROSCOPE FOUND THAT ADHESIVE WAS PRESENT BETWEEN THE BUTTON, GRIP, AND NEEDLE HUB ON UNIT 2. YOUR REPORTED ISSUE WAS CONFIRMED WITH THE EVALUATION OF UNIT 2. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO THE ADHESIVE DISPENSE PROCESS DUE TO STATION MISALIGNMENT, PART MISALIGNMENT OR ADHESIVE BUILDUP ON THE NOZZLE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. A TREND HAS BEEN IDENTIFIED FOR NEEDLE RETRACTION FAILURE REPORTED FAILURES FOR THE IMPLICATED LOT NUMBER.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 23-JAN-2023. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED FIVE SEALED 20G X 1.16IN. INSYTE AUTOGUARD UNITS FROM LOT NUMBER 2160587. THE UNITS WERE VISUALLY INSPECTED, AND NO DAMAGE OR DEFECTS WERE IDENTIFIED TO THE COMPONENTS. ALL UNITS WERE FUNCTIONALLY TESTED FOR NEEDLE RETRACTION AND ALL UNITS SUCCESSFULLY RETRACTED WITHOUT ISSUE. THE RETURNED UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN THE REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. ALTHOUGH THE REPORTED ISSUE WAS NOT CONFIRMED, A TREND HAS BEEN IDENTIFIED FOR NEEDLE RETRACTION FAILURE REPORTED FAILURES FOR THE IMPLICATED LOT NUMBER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16" THE NEEDLE DID NOT RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAVE HAD MULTIPLE CATHETERS, ALL FROM LOT#: 2160587, THAT DO NOT RETRACT THE NEEDLE WHEN THE BUTTON IS PRESSED.
IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16" THE NEEDLE DID NOT RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAVE HAD MULTIPLE CATHETERS, ALL FROM LOT# 2160587, THAT DO NOT RETRACT THE NEEDLE WHEN THE BUTTON IS PRESSED.
IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16" THE NEEDLE DID NOT RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAVE HAD MULTIPLE CATHETERS, ALL FROM LOT# 2160587, THAT DO NOT RETRACT THE NEEDLE WHEN THE BUTTON IS PRESSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2282131 | BD INSYTE AUTOGUARD STRAIGHT, 20G X 1.16" | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 381434 | 2160587 | 00382903814343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |