BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 9356929 · Received November 21, 2019

    Report

    Report Number
    1213809-2019-01169
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 4, 2019
    Report Date
    January 14, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION:ONE PHOTO OF A LOOSE 10ML SYRINGE NEXT TO THE TOP WEB OF A BLISTER PACK FROM BATCH 9150973 (P/N 302995) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A LENGTHWISE CRACK EXTENDING FROM THE ZERO LINE TO THE 9ML MARKING. THERE WAS A HOLE IN THE CENTER OF THE CRACK APPROXIMATELY 1/3" IN DIAMETER. THE DAMAGE WAS REJECTABLE PER PRODUCT SPECIFICATION. FIFTY-THREE 10ML SYRINGES WERE RECEIVED AND EVALUATED. FIFTY-TWO WERE IN FULLY SEALED BLISTER PACKS FROM BATCH 9150973 (P/N 302995) AND ONE WAS LOOSE. IT WAS OBSERVED FOUR OF THE SYRINGES CONTAINED A CRACK IN THE BARREL AND TWO OF THE FOUR ALSO HAD A CRACK IN THE PLUNGER ROD. THREE OF THE SYRINGES HAD A CRACK AT THE BOTTOM OF THE BARREL THAT EXTENDED UPWARDS WITH SIGNIFICANT PUNCTURE DAMAGE, AND ONE SYRINGE HAD A CRACK AT THE TOP OF THE BARREL THAT EXTENDED DOWNWARD. THE FOUR SYRINGES CONTAINING DAMAGE WERE REJECTABLE PER PRODUCT SPECIFICATION. MACHINE LOGS INDICATE THERE WERE JAMS DURING THE MANUFACTURE OF THIS BATCH. POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT WAS LIKELY CAUSED BY A JAM AT THE ASSEMBLY DIALS. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CRACKED BARRELS WERE FOUND BEFORE USE WITH BD SYRINGES LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WE HAD TWO MORE SYRINGES COME TO US FROM THE SAME LOT WITH HOLES." 2.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CRACKED BARRELS WERE FOUND BEFORE USE WITH BD SYRINGES LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WE HAD TWO MORE SYRINGES COME TO US FROM THE SAME LOT WITH HOLES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153716 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9150973 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other