BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1.0ML 29GA 1/2IN BLS 500 CHINA

    MDR report key: 16698666 · Received April 7, 2023

    Report

    Report Number
    1920898-2023-00199
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    March 9, 2023
    Report Date
    April 27, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    00382908421010
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. CUSTOMER RETURNED TWO PHOTOS OF THE 29 GUAGE SYRINGES IN OPEN BLISTER PACKS FROM LOT # 1242485. THE CUSTOMER REPORTED THAT THERE WERE 36 SYRINGE PRODUCTS WITH OPENED EDGE ISSUE. THE PHOTOS WERE EXAMINED, AND REVEALED MULTIPLE BLISTER PACKS OPEN FROM THE SEAL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1242485. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE BLISTERPACK (OPEN PACKAGE/SEAL). ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE 1.0ML 29GA 1/2IN BLS 500 CHINA THE PACKAGING WAS DAMAGED AND UNSTERILE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER FURTHER CONFIRMING WITH CUSTOMER, THERE WERE 36 SYRINGE PRODUCTS WITH 'OPENED EDGE' ISSUE WHEN THE HOSPITAL SUPPLY ROOM DISTRIBUTED THE SYRINGES, IT WAS FOUND THAT THE INSIDE PACKAGE WAS DAMAGED, AND THE SURFACE OF THE SYRINGES FAILED TO MEET THE STERILITY REQUIREMENTS, SO THE DISTRIBUTION WAS STOPPED IMMEDIATELY AND IT WAS NOT FOR CLINICAL USE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE 1.0ML 29GA 1/2IN BLS 500 CHINA THE PACKAGING WAS DAMAGED AND UNSTERILE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER FURTHER CONFIRMING WITH CUSTOMER, THERE WERE 36 SYRINGE PRODUCTS WITH 'OPENED EDGE' ISSUE. WHEN THE HOSPITAL SUPPLY ROOM DISTRIBUTED THE SYRINGES, IT WAS FOUND THAT THE INSIDE PACKAGE WAS DAMAGED, AND THE SURFACE OF THE SYRINGES FAILED TO MEET THE STERILITY REQUIREMENTS, SO THE DISTRIBUTION WAS STOPPED IMMEDIATELY AND IT WAS NOT FOR CLINICAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730413 BD SYRINGE 1.0ML 29GA 1/2IN BLS 500 CHINA HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 1242485 00382908421010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown