BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET 33GA 100 COUNT US

    MDR report key: 9975400 · Received April 17, 2020

    Report

    Report Number
    9616657-2020-00061
    Event Type
    Malfunction
    Date Received
    April 17, 2020
    Date of Event
    March 29, 2020
    Report Date
    April 20, 2020
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMK
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LANCET 33GA 100 COUNT US WAS MISSING LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 322057 BATCH NO: 9014779, 2242135 IT WAS REPORTED THAT PHARMACY RECEIVED LANCETS WITHOUT MANUFACTURE DATE AND EXPIRATION DATE. RECEIVED FROM EMAIL: HI, I HAVE BD ULTRA-FINE 33G LANCETS WITHOUT MANUFACTURE DATE AND EXPIRATION DATE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9014779, MEDICAL DEVICE EXPIRATION DATE: N/A, DEVICE MANUFACTURE DATE: 2009-01-26, MEDICAL DEVICE LOT #: 2242135, MEDICAL DEVICE EXPIRATION DATE: N/A, DEVICE MANUFACTURE DATE: 2012-09-12. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LANCET 33GA 100 COUNT US WAS MISSING LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 322057 BATCH NO: 9014779, 2242135. IT WAS REPORTED THAT PHARMACY RECEIVED LANCETS WITHOUT MANUFACTURE DATE AND EXPIRATION DATE. RECEIVED FROM EMAIL: HI, I HAVE BD ULTRA-FINE 33G LANCETS WITHOUT MANUFACTURE DATE AND EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435552 LANCET 33GA 100 COUNT US LANCET FMK BECTON, DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other