BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK TIP

    MDR report key: 9366901 · Received November 23, 2019

    Report

    Report Number
    1213809-2019-01172
    Event Type
    Malfunction
    Date Received
    November 23, 2019
    Date of Event
    November 6, 2019
    Report Date
    December 17, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE PHOTO AND ONE LOOSE 1ML LL SYRINGE INSIDE AN OPENED BLISTER PACKAGE FROM BATCH #9170679 (P/N 309628) WAS RECEIVED. THE SAMPLE WAS VISUALLY EVALUATED. THE BARREL HAD NO SCALE MARKINGS AT ALL PRESENT ON ITS SURFACE. POTENTIAL ROOT CAUSE FOR THE SCALE MARKING DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. 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.

    Description of Event or Problem · 0

    MATERIAL NO.: 309628, BATCH NO.: 9170679. IT WAS REPORTED THAT BEFORE USE OF THE BD 1ML SYRINGE LUER-LOK¿ TIP THE SYRINGES HAD NO MARKINGS ON THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO MARKINGS ON THE SYRINGE. TECHNICIAN DID NOT USE THE FAULTY SYRINGE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO.: 309628 BATCH NO.: 9170679. IT WAS REPORTED THAT BEFORE USE OF THE BD 1ML SYRINGE LUER-LOK¿ TIP THE SYRINGES HAD NO MARKINGS ON THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO MARKINGS ON THE SYRINGE. TECHNICIAN DID NOT USE THE FAULTY SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161517 BD 1ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9170679 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other