INSYTE AUTOGUARD BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
Report
- Report Number
- 1710034-2020-00490
- Event Type
- Malfunction
- Date Received
- August 3, 2020
- Date of Event
- July 9, 2020
- Report Date
- September 10, 2020
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 30382903826330
- PMA / PMN Number
- K110443
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: ADDITIONAL LOT #: D.4. MEDICAL DEVICE LOT #: 0090867. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. H.4. DEVICE MANUFACTURE DATE: 2020-03-30.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES. D.10 RETURNED TO MANUFACTURER ON: 2020-07-27. H.6. INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED THIRTEEN UNUSED IAG BC 20GA UNITS IN SEALED PACKAGES FROM MATERIAL NUMBER 382633, LOT NUMBER 0111292 AND ONE UNUSED IAG BC 20GA UNIT IN A SEALED PACKAGE FROM MATERIAL NUMBER 382633, LOT NUMBER 0090867. A VISUAL / MICROSCOPIC EVALUATION WAS PERFORMED ON THE FOURTEEN RETURNED UNITS. IT WAS OBSERVED THAT COLOR OF THE ADAPTERS RANGED FROM ALMOST COLORLESS TO LIGHT PINK. FURTHER ANALYSIS WAS CONDUCTED BY COMPARING THE LUER END OF EACH PART TO A COLOR CHIP TO ASSURE COLOR WAS WITHIN NOMINAL RANGE. ALL FOURTEEN UNITS FAILED THE SPECIFICATION, CONFIRMING THE REPORTED ISSUE. BEFORE STARTUP OF THE MANUFACTURING PROCESS, THE COLOR FEEDER IS CLEARED AND THE NEW COLOR IS ADDED. DUE TO THE NO COLOR/SLIGHT COLOR OF THE UNITS, THE MOST PROBABLE CAUSE IS AN ERROR DURING THE COLOR CHANGE OVER PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.
IT WAS REPORTED THAT 20 BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETERS BLOOD CONTROL TECHNOLOGY WERE INCORRECTLY COLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT JELCOS SHOULD BE PINK, BUT ARE VERY PALE OR CLEAR IN COLOR. ISSUE: TODAY I WAS BROUGHT ABOUT 20 MORE JELCOS THAT SHOULD BE PINK THAT ARE VERY PALE OR CLEAR IN COLOR."
IT WAS REPORTED THAT 20 BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETERS BLOOD CONTROL TECHNOLOGY WERE INCORRECTLY COLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT JELCOS SHOULD BE PINK, BUT ARE VERY PALE OR CLEAR IN COLOR. ISSUE: TODAY I WAS BROUGHT ABOUT 20 MORE JELCOS THAT SHOULD BE PINK THAT ARE VERY PALE OR CLEAR IN COLOR."
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER 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. (B)(4).
IT WAS REPORTED THAT 20 BD INSYTE¿ AUTOGUARD¿ BC WINGED SHIELDED IV CATHETERS BLOOD CONTROL TECHNOLOGY WERE INCORRECTLY COLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT JELCOS SHOULD BE PINK, BUT ARE VERY PALE OR CLEAR IN COLOR. ISSUE: TODAY I WAS BROUGHT ABOUT 20 MORE JELCOS THAT SHOULD BE PINK THAT ARE VERY PALE OR CLEAR IN COLOR."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 818863 | INSYTE AUTOGUARD BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 382633 | 0111292 | 30382903826330 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |