BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML LL W/O DN

    MDR report key: 9521635 · Received December 26, 2019

    Report

    Report Number
    1213809-2019-01307
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    December 2, 2019
    Report Date
    February 19, 2020
    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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: ONE OPENED EMPTY PACKAGE AND TWO SEALED PACKAGED 1ML LL SYRINGES WERE RECEIVED. ALL PACKAGES WERE CONFIRMED TO BE FROM BATCH #9170678 (P/N 309628). THE SAMPLES WERE VISUALLY EVALUATED. NO DEFECTS WERE OBSERVED WITH THE EMPTY PACKAGE AS IT CONTAINED NO SAMPLE. THE TWO SYRINGES WERE OBSERVED TO HAVE INTACT PLUNGER RODS. THE PLUNGER RODS WERE PULLED OUT AND EVALUATED. NO CRACKS OR DAMAGE WAS OBSERVED. NO DEFECTS WERE FOUND WITH THE RETURNED SAMPLES. IT IS NOT ENTIRELY CLEAR WHAT THE FAILURE WAS SINCE NO PHOTOS WERE PROVIDED FOR REFERENCE. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. 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. 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 HAS BEEN REPORTED THAT THE BD¿ SYRINGE 1ML LL W/O DN HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF BROKEN PLUNGER RODS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: TWO CHEMOTHERAPY PREPARATIONS WITH SYRINGE, SYRINGE PLUNGER BREAKS AND LEAKAGE OF THE PRODUCT. RE-FABRICATION.

    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

    IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 1ML LL W/O DN HAS BEEN FOUND EXPERIENCING TWO OCCURRENCES OF BROKEN PLUNGER RODS DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: TWO CHEMOTHERAPY PREPARATIONS WITH SYRINGE, SYRINGE PLUNGER BREAKS AND LEAKAGE OF THE PRODUCT. RE-FABRICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316945 BD SYRINGE 1ML LL W/O DN PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 9170678 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other