BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LANCET 33GA

    MDR report key: 10090049 · Received May 26, 2020

    Report

    Report Number
    9616657-2020-00082
    Event Type
    Malfunction
    Date Received
    May 26, 2020
    Date of Event
    May 14, 2020
    Report Date
    May 19, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED. (B)(6) WAS USED AS A PLACE HOLDER BASED ON THE USER AREA CODE. INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR MISSING LABEL INFORMATION (EXPIRATION DATE) ON LOT # 0112209. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. THE REPORTED LOT NUMBER (0112209) WAS MANUFACTURED IN 2010. THE DHR IS LONGER AVAILABLE FROM MANUFACTURING AS THE MANUFACTURING SITE IS ONLY REQUIRED TO RETAIN THE DHR INFORMATION FOR 7 YEARS. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXPIRATION DATE WAS MISSING OFF OF LABEL AND DISCOVERED PRIOR TO USE WITH A BD LANCET 33 GA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2 COMPLAINTS) IT WAS REPORTED THAT THE PHARMACIST CALLED TO DETERMINE THE EXPIRATION DATE OF 2 BOXES OF THE BD LANCETS. ADVISED CONSUMER THAT BD HAS NOT MANUFACTURED THE BD LANCETS IN A FEW YEARS AND THESE BOXES WOULD BE EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553903 BD LANCET 33GA MANUAL SURGICAL INSTRUMENT FOR GENERAL USE FMK BECTON, DICKINSON AND CO. 0112209

    Patients

    Seq Age Sex Outcome Treatment
    1 Other