BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 6MM

    MDR report key: 11913529 · Received June 1, 2021

    Report

    Report Number
    1920898-2021-00621
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 4, 2021
    Report Date
    June 22, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED PHOTOS OF 1CC SYRINGES IN BLISTER PACKS FROM LOT # 0160430. CUSTOMER STATES THAT A HAIR (FILAMENT) THAT PASSES THROUGH BOTH BLISTERS. THE PHOTOS WERE EXAMINED AND EXHIBITED A STRAND OF MATERIAL CAUGHT IN THE SEALS OF THE BLISTER PACKS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0160430. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD SYRINGE 1.0ML 31GA 6MM WITH HAIR PASSED THROUGH THE SEALS ON THE UNIT PACKAGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED BY PHOTO SUBMISSION OF THE PRODUCT WITH A HAIR (FILAMENT) PASSING THROUGH BOTH BLISTER PACKS. QUANTITY: (B)(4) UNITS.

    Additional Manufacturer Narrative · 1

    (B)(6). INITIAL REPORTER ZIP CODE: UNKNOWN. A DEVICE EVALUATION IS PENDING BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD SYRINGE 1.0ML 31GA 6MM WITH HAIR PASSED THROUGH THE SEALS ON THE UNIT PACKAGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED BY PHOTO SUBMISSION OF THE PRODUCT WITH A HAIR (FILAMENT) PASSING THROUGH BOTH BLISTER PACKS. QUANTITY: 2 UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807781 SYRINGE 1.0ML 31GA 6MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0160430

    Patients

    Seq Age Sex Outcome Treatment
    1