BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL BNS

    MDR report key: 19399155 · Received May 26, 2024

    Report

    Report Number
    1213809-2024-00316
    Event Type
    Malfunction
    Date Received
    May 26, 2024
    Date of Event
    May 7, 2024
    Report Date
    November 15, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010733
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    TWO PHOTOS OF A 3ML LUER LOCK SYRINGE (P/N 301073) WERE RECEIVED AND EVALUATED. BOTH PHOTOS SHOW ONE LOOSE SYRINGE FROM DIFFERENT ANGLES WITH AN UNKNOWN WHITE PARTICULATE ON THE SIDE OF THE STOPPER. PHYSICAL SAMPLE IS REQUIRED TO FURTHER ANALYZE AND IDENTIFY THE FOREIGN SUBSTANCE. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER FLUID PATH IS ASSOCIATED WITH THE ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A COMPLAINT WAS RECEIVED FROM OUR CUSTOMER STATING THAT SYRINGES CONTAMINATED WITH WHITE PARTICLES WERE FOUND. THE CONTAMINATION IS INSIDE THE SYRINGES, ON THE PLUNGER. IT DESCRIBED THAT A LARGE NUMBER OF SYRINGES IN ONE ORDER WERE CONTAMINATED. THE QUANTITY OF THIS ORDER IS OF 972 PIECES. VENDOR BATCH USED FOR PRODUCTION IS 2223871 PLEASE SEE THE ATTACHED PHOTOS AND FILL IN THE FIELDS BELOW WITH YOUR STATEMENT AND CORRECTIVE ACTION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2300831 BD SYRINGE 3ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2223871 50382903010733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown