BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET 33GA 100 COUNT US

    MDR report key: 10143191 · Received June 11, 2020

    Report

    Report Number
    9616657-2020-00089
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    May 22, 2020
    Report Date
    November 25, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: 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. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS 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. 6041753. IT WAS REPORTED THAT EXPIRATION DATE IS MISSING FROM BOX.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LANCET 33 GA 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. 6041753. IT WAS REPORTED THAT EXPIRATION DATE IS MISSING FROM BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610147 LANCET 33GA 100 COUNT US MANUAL SURGICAL INSTRUMENT FOR GENERAL USE FMK BECTON DICKINSON AND CO. 6041753

    Patients

    Seq Age Sex Outcome Treatment
    1 Other