BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 11033025 · Received December 17, 2020

    Report

    Report Number
    1911916-2020-01125
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 19, 2020
    Report Date
    December 7, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9337406, MEDICAL DEVICE EXPIRATION DATE: 2024-11-30, DEVICE MANUFACTURE DATE: 2019-12-03, MEDICAL DEVICE LOT #: 9337407, MEDICAL DEVICE EXPIRATION DATE: 2024-11-30, DEVICE MANUFACTURE DATE: 2019-12-03, MEDICAL DEVICE LOT #: 0062237, MEDICAL DEVICE EXPIRATION DATE: 2025-02-28, DEVICE MANUFACTURE DATE: 2020-03-02." NITIAL REPORTER PHONE #: (B)(6). (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301035 AND LOT NUMBER 9337406. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, NINETY SYRINGES AND THREE PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SYRINGES CAME IN THREE DIFFERENT PLASTIC BAGS AND EACH BAG IS LABELED WITH 30 PCS AND A LOT NUMBER - LOT NUMBERS 9337406, 9337407 AND 00062237. A VISUAL INSPECTION WAS PERFORMED, NO DAMAGES OR DEFECTS WERE OBSERVED. THERE ARE SOME MINOR RUB MARKS ON THE BARRELS, BUT ALL ARE ACCEPTABLE. IN THE THREE PHOTOS PROVIDED NO DEFECTS OR IMPERFECTIONS ARE OBSERVED. BASED ON THE INVESTIGATION RESULTS, THE SAMPLES RECEIVED DID NOT SHOW THE SYMPTOM REPORTED BY THE CUSTOMER AND AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD¿ LUER-LOK SYRINGE THE BARRELS WERE DISCOVERED TO BE CRACKED. THERE WERE 2875 CRACKED WITH LOT# 9337406, 33,750 CRACKED WITH LOT# 9337407 AND 3375 WITH LOT# 0062237. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THERE ARE MARKS ON THE SYRINGES. PICTURES PROVIDED SHOW THAT THE BARRELS ARE CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495665 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1