BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD 3 ML SYRINGE

    MDR report key: 9827053 · Received March 12, 2020

    Report

    Report Number
    2243072-2020-00388
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    February 24, 2020
    Report Date
    April 28, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION. D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-02-27. H.6. INVESTIGATION SUMMARY: SAMPLE AND PHOTO RECEIVED FOR INVESTIGATION. SAMPLE WAS EVALUATED FOR LEAKAGE AND/OR MOLDING DEFECTS. DURING THE VISUAL INSPECTION OF THE SAMPLE SENT BY THE CLIENT, IT WAS OBSERVED THAT IT PRESENTS ASPIRATION ISSUES AT THE LUER TIP, NO LEAKAGE DEFECT IS PRESENT. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. CORRECTIVE AND PREVENTATIVE ACTION CAPA 1132752 WAS OPENED TO INVESTIGATE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DEFECTIVE MOLDING WAS FOUND DURING USE WITH A UNSPECIFIED BD 3 ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "REGARDING THE REPORTED ISSUE OF AN EXTENSION SET LEAK SD CAD FUNCTIONALITY TESTED THE RECEIVED SAMPLES AND OBSERVED THE LEAK TO ONLY OCCUR WITH THE SYRINGE. EXAMINATION OF THE SYRINGE OBSERVED A DEFORMED SECTION NEAR THE BASE OF THE SYRINGE LUER TIP. HERE IS THE INFORMATION FOR THE RECEIVED BD 3ML SYRINGE: BD 3ML SYRINGE LOT UNKNOWN / BARREL FLANGE MOLD NUMBER M-143 AND CAVITY 2."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG OR A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT, AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 DEFECTIVE MOLDING WAS FOUND DURING USE WITH A UNSPECIFIED BD 3 ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "REGARDING THE REPORTED ISSUE OF AN EXTENSION SET LEAK SD CAD FUNCTIONALITY TESTED THE RECEIVED SAMPLES AND OBSERVED THE LEAK TO ONLY OCCUR WITH THE SYRINGE. EXAMINATION OF THE SYRINGE OBSERVED A DEFORMED SECTION NEAR THE BASE OF THE SYRINGE LUER TIP. HERE IS THE INFORMATION FOR THE RECEIVED BD 3ML SYRINGE: BD 3ML SYRINGE LOT UNKNOWN / BARREL FLANGE MOLD NUMBER M-143 AND CAVITY 2."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291149 UNSPECIFIED BD 3 ML SYRINGE SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other