BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD SYRINGE

    MDR report key: 12230223 · Received July 27, 2021

    Report

    Report Number
    2243072-2021-01967
    Event Type
    Malfunction
    Date Received
    July 27, 2021
    Date of Event
    June 28, 2021
    Report Date
    July 9, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, (B)(6) USA HAS BEEN USED AS A PLACEHOLDER BASED ON THE REPORTED PHONE AREA CODE. DEVICE MANUFACTURE DATE: UNKNOWN. 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. DUE TO THE BATCH BEING UNKNOWN, NO DHR REVIEW CAN BE COMPLETED. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD" SYRINGE WAS DIFFICULT TO OPERATE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER LEFT VOICEMAIL REQUESTING CALL BACK REGARDING PRODUCT COMPLAINT. MKB".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128984 UNSPECIFIED BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1