BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 8961065 · Received September 4, 2019

    Report

    Report Number
    1920898-2019-00904
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 13, 2019
    Report Date
    September 20, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED PHOTOS OF SHELF CARTONS FOR 1/2CC, 6MM, 31G SYRINGES FROM LOT#: 5222579. CUSTOMER STATES THAT THE BOX IS DAMAGED AND THE LOT IS BURRED AND EXPIRED. THE ATTACHED PHOTOS WERE EXAMINED AND EXHIBITED TORN SHELF CARTONS. ALL LOT NUMBERS WERE PRINTED CLEARLY ON THE SHELF CARTONS AND THE EXPIRATION DATE PRINTED ON THE SHELF CARTON IN THE ATTACHED PHOTOS READS AS AUGUST 2020, WHICH INDICATES THAT THE PRODUCT IS NOT EXPIRED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 5222579. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (TORN SHELF CARTONS). BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BLURRY AND EXPIRED LOT). H3 OTHER TEXT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DAMAGED PACKAGING WAS FOUND BEFORE USE WITH A BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "DAMAGED BOX, BLURRED AND EXPIRED LOT, CODE: 324917, BATCH: 5222579". 7 OCCURRENCES WERE REPORTED, BUT THE DATES/TIMES WERE NOT GIVEN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, 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 DAMAGED PACKAGING WAS FOUND BEFORE USE WITH A BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DAMAGED BOX BLURRED AND EXPIRED LOT CODE: 324917 BATCH: 5222579" 7 OCCURRENCES WERE REPORTED, BUT THE DATES/TIMES WERE NOT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754429 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE SYRINGE FMF BD MEDICAL - DIABETES CARE 5222579

    Patients

    Seq Age Sex Outcome Treatment
    1 Other