BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ SHORT NEEDLE INSULIN SYRINGES 1ML 0.33MM (29G) X 12.7MM U-100

    MDR report key: 14951655 · Received July 7, 2022

    Report

    Report Number
    1920898-2022-00437
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    June 9, 2022
    Report Date
    July 7, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR BLISTERPACK PACKAGE POOR PERFORATION ON LOT # 1173030. INVESTIGATION SUMMARY: CUSTOMER RETURNED (8) 1ML, 12.7MM, 29G SYRINGES IN SEALED BLISTER PACKS FROM LOT # 1173030. CUSTOMER STATES THAT THERE IS NO PARTING/TEARING LINE ON PACKAGING TO SEPARATE THE INDIVIDUAL SYRINGES. ALL RETURNED SYRINGES WERE EXAMINED AND NO PERFORATIONS WERE OBSERVED BETWEEN THE BLISTER PACKS OF THE SYRINGES. MANUFACTURING (HOLDREGE) WILL BE NOTIFIED OF THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1173030. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE INVESTIGATION: THERE WERE NO QUALITY NOTIFICATIONS OR DISPATCHES THAT PERTAINED TO THE COMPLAINT, THEREFORE NO ROOT CAUSE CAN BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ SHORT NEEDLE INSULIN SYRINGES 1ML 0.33MM (29G) X 12.7MM U-100 THE PERFORATION WAS POOR. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ASP PACK INJECTING KITS AND HANDLE INDIVIDUALLY EACH SYRINGE INTO A KIT. THERE IS NO PARTING/TEARING LINE ON PACKAGING TO SEPARATE THE INDIVIDUAL SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504255 BD ULTRA-FINE¿ SHORT NEEDLE INSULIN SYRINGES 1ML 0.33MM (29G) X 12.7MM U-100 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1173030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown