BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 8241138 · Received January 11, 2019

    Report

    Report Number
    1911916-2018-00818
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 19, 2018
    Report Date
    February 7, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR THE SUSPECTED LOTS WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE APPEARED BURNT OR CONTAMINATED WITH MOLD PRIOR TO USE.

    Additional Manufacturer Narrative · 1

    THERE WERE TWO REPORTED LOT NUMBERS (7170615 AND 8113860), HOWEVER IT IS UNKNOWN WHICH IS CORRECT. LOT 7170615, MANUFACTURE DATE 2017-07-31, EXPIRATION DATE 2022-06-30; LOT 8113860, MANUFACTURE DATE 2018-06-18, EXPIRATION DATE 2023-04-30. (B)(6). 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 THE BD LUER-LOK¿ SYRINGE APPEARED BURNT OR CONTAMINATED WITH MOLD PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32430 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other