BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD PNK 20GA X 1.16IN

    MDR report key: 15450943 · Received September 19, 2022

    Report

    Report Number
    1710034-2022-00517
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    August 24, 2022
    Report Date
    October 31, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 13-OCT-2022 . H6: INVESTIGATION SUMMARY BD RECEIVED AN UNSEALED 20 GAUGE INSYTE AUTOGUARD DEVICE FROM LOT 2080983 FOR EVALUATION. NO SAMPLE WAS RECEIVED FOR LOT 2012824, WHICH WAS ALSO REPORTED TO HAVE BEEN AFFECTED BY THIS DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR BOTH REPORTED LOTS AND NO QUALITY ISSUES WERE FOUND AT THE TIME OF MANUFACTURING. OUR QUALITY ENGINEER MICROSCOPICALLY INSPECTED THE RETURNED UNIT AND OBSERVED SOME MEDIA INSIDE OF THE CATHETER AS WELL AS SOME DAMAGE ON THE INSIDE OF THE CATHETER ON THE SCREW THREAD. THERE WAS ALSO SOME DAMAGE FOUND ON THE OUTSIDE OF THE ADAPTER. AN ATTEMPT WAS MADE TO CONNECT A SYRINGE TO THE UNIT. THE SYRINGE WAS ABLE TO SCREW IN PROPERLY BUT AFTER A LITTLE BIT OF FORCE WAS APPLIED. HOWEVER, DUE TO THE DAMAGE OBSERVED ON THE OUTSIDE OF THE ADAPTER THE SYRINGE FAILED TO SCREW ON COMPLETELY. THEREFORE, BASED OFF THE MICROSCOPIC INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT THAT OCCURRED DUE TO INCORRECT SET UP OF THE MANUFACTURING EQUIPMENT.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2080983. MEDICAL DEVICE EXPIRATION DATE: 28FEB2025. DEVICE MANUFACTURE DATE: 28MAR2022. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD PNK 20GA X 1.16IN THE CONNECTOR COULD NOT BE ATTACHED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER PLACED ON A PATIENT TODAY. SCREW THREAD FAILED: UNABLE TO SCREW IN INFUSION. USE OF THE SAME BATCH AS THE FAULTY ONE BUT NO SCREW THREAD PROBLEM. THIS PROBLEM OCCURRED WITH BATCH 2012824 IN MAY, BUT THE DEVICE WAS NOT RETAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE AUTOGUARD PNK 20GA X 1.16IN THE CONNECTOR COULD NOT BE ATTACHED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER PLACED ON A PATIENT TODAY. SCREW THREAD FAILED: UNABLE TO SCREW IN INFUSION. USE OF THE SAME BATCH AS THE FAULTY ONE BUT NO SCREW THREAD PROBLEM. THIS PROBLEM OCCURRED WITH BATCH 2012824 IN (B)(6), BUT THE DEVICE WAS NOT RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123822 BD INSYTE AUTOGUARD PNK 20GA X 1.16IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381834 2012824 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown