BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 7898488 · Received September 21, 2018

    Report

    Report Number
    1911916-2018-00519
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    September 3, 2018
    Report Date
    November 6, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903010318
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. DHR: NO ISSUES RELATED TO THESE COMPLAINTS WERE RECORDED WHILE PRODUCING THESE BATCHES. NO QNS WERE ISSUED AS WELL EXCEPT FOR BATCH 7080847 WHICH HAD ONE QN FOR THIN INK. HOWEVER WITHOUT PHOTOS OR SAMPLE, WE CANNOT DETERMINE IF THIS WAS THE ISSUE FOR THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK SYRINGES HAD FOREIGN MATTER AND SCALE MARKING ERROR. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    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 #: 7080847, MEDICAL DEVICE EXPIRATION DATE: 2022-03-31 , DEVICE MANUFACTURE DATE: 2017-03-21 . MEDICAL DEVICE LOT #: 7143808, MEDICAL DEVICE EXPIRATION DATE: 2022-05-31, DEVICE MANUFACTURE DATE: 2017-05-23. MEDICAL DEVICE LOT #: 7143831, MEDICAL DEVICE EXPIRATION DATE: 2022-05-31, DEVICE MANUFACTURE DATE: 2017-05-23. MEDICAL DEVICE LOT #: 7262511 , MEDICAL DEVICE EXPIRATION DATE: 2022-09-30, DEVICE MANUFACTURE DATE: 2017-09-19 . 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 BD LUER-LOK¿ SYRINGES HAD FOREIGN MATTER AND SCALE MARKING ERROR. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737857 BD LUER-LOK¿ SYRINGE SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10 00382903010318

    Patients

    Seq Age Sex Outcome Treatment
    1 Other