BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ SYRINGE

    MDR report key: 15794852 · Received November 14, 2022

    Report

    Report Number
    2243072-2022-01951
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    July 11, 2022
    Report Date
    November 5, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(6). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INITIAL REPORTER PHONE#: UNKNOWN. INITIAL REPORTER E-MAIL: UNKNOWN. INVESTIGATION SUMMARY: THE TEN PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO OF A DISCARDIT 2ML WITH 25GX1 NEEDLE FROM LOT #: 2150646 REGARDING ITEM #: 302438 WITH THE REPORTED COMPLAINT OF MULTIPLE DEFECTS (MARKING DEFECTS) IN THE SYRINGE. THE INVESTIGATING TEAM HAS USED THE RETENTION SAMPLES OF LOT #: 2150646 REGARDING ITEM #: 302438 FOR INVESTIGATING THE REPORTED DEFECT. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES FOR MULTIPLE DEFECTS (MARKING DEFECTS) IN SYRINGE AND NO DEFECT IN SYRINGE WAS FOUND IN THE RETENTION SAMPLES. THE INVESTIGATION WAS ALSO CARRIED OUT ON THE PHOTOGRAPH AS WELL. THE PHOTOGRAPH CONFIRMS THE REPORTED DEFECT IN THE SYRINGE. THE INVESTIGATING TEAM HAS REQUESTED FOR THE DEFECTIVE SAMPLES TO BE RETURNED FOR A THOROUGH INVESTIGATION AND FINDING THE ROOT CAUSE, TO HAVE A PROPER CORRECTIVE AND PREVENTIVE ACTIONS. AN INVESTIGATING TEAM MEMBER WILL ALSO VISIT THE CUSTOMERS STORAGE FACILITY FOR HELPING RESOLVE THESE ISSUES. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 103 BD DISCARDIT¿ SYRINGES HAD MISSING SCALE MARKINGS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "15750 UNITS HAVING DEFECTS LIKE... MARKING DEFECTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121064 BD DISCARDIT¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 2150646

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown