BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AG BC GLOBAL

    MDR report key: 19294000 · Received May 10, 2024

    Report

    Report Number
    1710034-2024-00428
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    April 16, 2024
    Report Date
    June 27, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903810123
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATES TO TAB B PROVIDES THE ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONFIRMING THAT A SOILED NEEDLESTICK OCCURRED AND THAT NO SERIOUS INJURY HAS RESULTED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT THAT THE NEEDLE WOULD NOT FULLY RETRACT WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. ONE 24G INSYTE AUTOGUARD UNIT FROM LOT #3240092 WAS PROVIDED FOR INVESTIGATION. THE NEEDLE WAS PARTIALLY RETRACTED, BUT THE NEEDLE TIP REMAINED PROTRUDING FROM THE GRIP. THE BARREL WAS DAMAGED, WHICH PREVENTED THE NEEDLE HUB FROM FULLY RETRACTING. THE CAUSE OF THE BARREL DAMAGE COULD NOT BE DETERMINED. NO OTHER SIMILAR COMPLAINTS WERE REPORTED FROM THE IMPLICATED LOT. A REVIEW OF THE INSPECTION RECORDS AND QUALITY/MANUFACTURING CONTROLS FOR THE IMPLICATED LOT INDICATED NO ISSUES WITH THE MANUFACTURING PROCESS. THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    PLEASE CONFIRM THAT A SOILED NEEDLESTICK OCCURRED. YES. DID THE PROVIDER REQUIRE DIAGNOSTICS OR TREATMENT TO PREVENT SERIOUS INJURY? YES. IF YES PLEASE PROVIDE DETAILS. BLOOD TEST.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AG BC GLOBAL NEEDLE DID NOT COMPLETELY RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: IT WAS REPORTED THAT TO RETRACT THE NEEDLE INTO THE BARREL AFTER PUNCTURE, THE BUTTON WAS PRESSED TO RETRACT THE NEEDLE INTO THE BARREL AFTER THE PUNCTURE, BUT IT WAS NOT FULLY RETRACTED AND THE NEEDLE POPPED OUT A LITTLE, CAUSING THE SURGEON TO PUNCTURE THE NEEDLE. THE NURSE SAID THERE WAS NO PROBLEM AFTER THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921267 BD INSYTE AG BC GLOBAL PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3240092 00382903810123

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other