BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ TUBERCULIN SYRINGE WITH THE BD PRECISIONGLIDE¿ DETACHABLE NEEDLE

    MDR report key: 16109205 · Received January 5, 2023

    Report

    Report Number
    1213809-2022-01340
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 9, 2022
    Report Date
    January 31, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096237
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NINETY-EIGHT SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT FIVE SAMPLES HAD SOME EMBEDDED BURNING/ BROWNISH FOREIGN MATTER IN THE BARREL AND FLANGE AREA. POTENTIAL ROOT CAUSE FOR THE EMBEDDED BURNING DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2131736. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BROWN FOREIGN MATTER WAS FOUND IN 2 BD¿ TUBERCULIN SYRINGES WITH THE BD PRECISIONGLIDE¿ DETACHABLE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE SEEING SOME ¿STUFF¿ INSIDE THE SYRINGES THAT SHOULD NOT BE THERE. I HAVE AN OPENED ONE AND ONE STILL IN THE STERILE PACKAGE. SOMETHING BROWN¿."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BROWN FOREIGN MATTER WAS FOUND IN 2 BD¿ TUBERCULIN SYRINGES WITH THE BD PRECISIONGLIDE¿ DETACHABLE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE SEEING SOME ¿STUFF¿ INSIDE THE SYRINGES THAT SHOULD NOT BE THERE. I HAVE AN OPENED ONE AND ONE STILL IN THE STERILE PACKAGE. SOMETHING BROWN¿."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313633 BD¿ TUBERCULIN SYRINGE WITH THE BD PRECISIONGLIDE¿ DETACHABLE NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2131736 00382903096237

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown