BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE INTEGRA 3ML W/NDL 25X1 RB

    MDR report key: 11052158 · Received December 21, 2020

    Report

    Report Number
    1213809-2020-00909
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    November 21, 2020
    Report Date
    November 25, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052708
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE INTEGRA 3ML W/NDL 25X1 RB HAD NEEDLE RETRACTION FAILURE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO: 305270, BATCH NO: 9093523. IT WAS REPORTED THAT THE SYRINGES ARE NOT RETRACTING. EVENT DESCRIPTION PER EMAIL STATES: PLEASE SEE ATTACHED INCIDENT REPORT REGARDING THE BD INTEGRA SYRINGE. WE HAVE NOTED THAT THE SYRINGES FROM THE LOT MENTION IN THE REPORT HAVE NOT RETRACTED IN SEVERAL INSTANCES (3-4). PLEASE LET ME KNOW WHETHER YOU HAVE HAD SIMILAR COMPLAINTS/ISSUES WITH THIS LOT AND WHETHER YOU WOULD RECOMMEND DISCONTINUING IT'S USE. QUESTIONS/INQUIRIES: WHAT IS THE DATE OF THE INCIDENT(S)? ARE THE AFFECTED SAMPLES TO BE SENT BACK FOR EVALUATION? IF SO, ARE THOSE SAMPLES CONTAMINATED. DO YOU HAVE AN APPROVED CANISTER TO SHIP THE AFFECTED SAMPLES FOR EVALUATION? IF THE AFFECTED SAMPLES ARE NOT AVAILABLE, WERE THERE ANY PHOTOS TAKEN DURING THE TIME OF INCIDENT? IF SO, PLEASE ATTACH IN RESPONSE EMAIL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511618 SYRINGE INTEGRA 3ML W/NDL 25X1 RB PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 305270 9093523 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1