BD INSYTE¿ AUTOGUARD¿ IV CATHETER
Report
- Report Number
- 9610048-2022-00122
- Event Type
- Malfunction
- Date Received
- October 12, 2022
- Date of Event
- September 20, 2022
- Report Date
- January 19, 2023
- Manufacturer
- BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
- Product Code
- FOZ
- UDI-DI
- 00382903818334
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- 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: 13-JAN-2023. H6: INVESTIGATION SUMMARY: BD RECEIVED FIVE UNUSED INSYTE AUTOGUARD 20 GAUGE DEVICES FROM LOT 2181472 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS AND OBSERVED NO VISIBLE DEFORMITIES. NEXT, THE ENGINEER ATTEMPTED TO RETRACT EACH NEEDLE AND OBSERVED NO ISSUES WITH THE RETRACTIONS. THEREFORE, BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, SINCE THERE WERE NO DEFECTS FOUND DURING INSPECTION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.
H6: INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO BUT COULD ONLY IDENTIFY AN EMPTY BLISTER PACKAGE WITH THE PRODUCT LOT LABELED AT THE TOP OF THE PACKAGE. THE ACTUAL DEVICE OR DEFECT WERE NOT VISIBLE. THEREFORE, BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. FOR A MORE THOROUGH INVESTIGATION A PHYSICAL SAMPLE OR PHOTO OF THE ACTUAL DEFECT WOULD BE REQUIRED. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR SUB-ASSEMBLY #(B)(4) LOT 2088487 MANUFACTURED FROM 20-APR-2022 TO 29-APR-2022 USED IN COMPLAINT LOT 2181472. THE BATCH WAS ANALYZED FOR "NEEDLE RETRACTION" AND ¿PART ACTIVATION¿ TESTS, AND THERE WAS EVIDENCE OF ACTIVATION FAILURE RECORDS THAT MAY BE RELATED TO THE REPORTED DEFECT.
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¿ IV CATHETER NEEDLE WOULD NOT RETRACT WHEN THE SAFETY DEVICE BUTTON WAS PRESSED. THIS OCCURRED WITH 5 CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "I REPORT 5 CASES OF CATHETER NUMBER 20 THAT DID NOT WORK SAFETY VALVE TO PROTECT THE NEEDLE. NURSING ACTIVATES THE WHITE BUTTON AND DOES NOT TRIGGER THE SAFETY DEVICE."
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ IV CATHETER NEEDLE WOULD NOT RETRACT WHEN THE SAFETY DEVICE BUTTON WAS PRESSED. THIS OCCURRED WITH 5 CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "I REPORT 5 CASES OF CATHETER NUMBER 20 THAT DID NOT WORK SAFETY VALVE TO PROTECT THE NEEDLE. NURSING ACTIVATES THE WHITE BUTTON AND DOES NOT TRIGGER THE SAFETY DEVICE."
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ IV CATHETER NEEDLE WOULD NOT RETRACT WHEN THE SAFETY DEVICE BUTTON WAS PRESSED. THIS OCCURRED WITH 5 CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "I REPORT 5 CASES OF CATHETER NUMBER 20 THAT DID NOT WORK SAFETY VALVE TO PROTECT THE NEEDLE. NURSING ACTIVATES THE WHITE BUTTON AND DOES NOT TRIGGER THE SAFETY DEVICE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2658011 | BD INSYTE¿ AUTOGUARD¿ IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. | 2181472 | 00382903818334 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |