BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA

    MDR report key: 16729155 · Received April 12, 2023

    Report

    Report Number
    1710034-2023-00413
    Event Type
    Malfunction
    Date Received
    April 12, 2023
    Date of Event
    March 15, 2023
    Report Date
    May 9, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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: 05-APR-2023. H6: INVESTIGATION SUMMARY: BD RECEIVED A SEALED 22 GAUGE INSYTE AUTOGUARD DEVICE FROM LOT 2243842 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 UNIT AND OBSERVED NO VISIBLE DAMAGE OR DEFORMITIES. NEXT, THE ENGINEER ATTEMPTED TO BREAK THE TIP ADHESION ON THE UNIT AND RETRACT THE NEEDLE. THE ENGINEER OBSERVED SOME RESISTANCE WHEN ATTEMPTING TO BREAK THE ADHESION. NEXT, THE ENGINEER USED A MICROSCOPE TO INSPECT THE DEVICE'S TIP. EXCESSIVE LUBE WAS FOUND ON THE TIP. FINALLY, THE ENGINEER ATTEMPTED TO RETRACT THE DEVICE AFTER BREAKING THE TIP ADHESION. THE DEVICE RETRACTED SUCCESSFULLY WITH NO RESISTANCE OR DELAY OBSERVED. THEREFORE, BASED OFF THE VISUAL/MICROSCOPIC INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY AN ISSUE WITH THE TIP ADHESION BUT COULD NOT VERIFY ANY ISSUES WITH THE NEEDLE RETRACTION. DURING THE LUBRICATION PROCESS SILICONE WAS PLACED ON THE CATHETER FOR TIPPING AND INCORRECT EQUIPMENT SETTINGS CAN CAUSE AN EXCESSIVE AMOUNT OF LUBE TO BE ADMINISTERED.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA THE NEEDLE DID NOT PROPERLY RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAN YOU PLEASE PROVIDE THE REF# OF THE PRODUCT? UNKNOWN. CAN YOU PLEASE PROVIDE THE LOT# OF THE PRODUCT? LOT #2243842. WAS THERE ANY PATIENT IMPACT? NO PATIENT IMPACT ¿ RN HAD TO GET ANOTHER NEEDLE. IF SO, WHAT WAS THE OUTCOME? N/A. CAN YOU DESCRIBE IN DETAIL WHAT THE REPORTED ISSUE IS? THE TECHS ARE REPORTING THAT THE CATHETER IS STICKING AND THE BUTTON IS NOT ALWAYS RETRACTING THE NEEDLE ON THE FIRST PRESS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA THE NEEDLE DID NOT PROPERLY RETRACT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CAN YOU PLEASE PROVIDE THE REF# OF THE PRODUCT? UNKNOWN CAN YOU PLEASE PROVIDE THE LOT# OF THE PRODUCT? LOT #2243842 WAS THERE ANY PATIENT IMPACT? NO PATIENT IMPACT ¿ RN HAD TO GET ANOTHER NEEDLE IF SO, WHAT WAS THE OUTCOME? N/A CAN YOU DESCRIBE IN DETAIL WHAT THE REPORTED ISSUE IS? THE TECHS ARE REPORTING THAT THE CATHETER IS STICKING AND THE BUTTON IS NOT ALWAYS RETRACTING THE NEEDLE ON THE FIRST PRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306147 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22GA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381423 2243842 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown