BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 29GA 1/2IN 200BX CA

    MDR report key: 11404763 · Received March 3, 2021

    Report

    Report Number
    1920898-2021-00251
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    February 4, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT A PACKAGE OF SYRINGE 0.5ML 29GA 1/2IN 200BX CA HAD MISSING LABEL INFORMATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT INFORMATION LABEL WAS MISSING." H.6. INVESTIGATION: CUSTOMER RETURNED AN IMAGE OF TWO SEPARATE SHIPPING CARTONS. ONE FEATURES A RED AND WHITE BD IDENTIFICATION LABEL. THE OTHER, FACING THE SAME DIRECTION AS THE FIRST, DOES NOT FEATURE ANY IDENTIFICATION LABEL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0160025. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A L2L DISPATCH WAS CREATED FOR THE MACHINE NOT INSTALLING LABELS. EXCESSIVE CARTONS WERE EJECTING FOR MISSING LABELS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PACKAGE OF SYRINGE 0.5ML 29GA 1/2IN 200BX CA HAD MISSING LABEL INFORMATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT INFORMATION LABEL WAS MISSING.

    Additional Manufacturer Narrative · 1

    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. "

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PACKAGE OF SYRINGE 0.5ML 29GA 1/2IN 200BX CA HAD MISSING LABEL INFORMATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT INFORMATION LABEL WAS MISSING. VERBATIM: FYI LOT IS 0160025. FOUND ON DATE OF RECEIPT 2/3/21 THE ITEM IN QUESTION ARRIVED TO OUR FACILITY DAMAGED. THE EXTERNAL SHIPPING CONTAINER WAS NOT VISIBLY DAMAGED. ITEM FOUND DAMAGED UPON OPENING EXTERNAL SHIPPING CONTAINER. PLEASE SEE THE ATTACHMENT. CUSTOMER IS STATING THERE ISN'T A LABEL ON THEIR PACKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303723 SYRINGE 0.5ML 29GA 1/2IN 200BX CA PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0160025

    Patients

    Seq Age Sex Outcome Treatment
    1