BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 9594119 · Received January 15, 2020

    Report

    Report Number
    1213809-2020-00006
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    December 12, 2019
    Report Date
    January 28, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: TWO PHOTOS AND 18 USED 10ML SYRINGES IN THREE ZIP LOCK BAGS, FILLED TO NOMINAL CAPACITY WITH CLEAR LIQUID MEDICATION, WERE RECEIVED. TWO BAGS WERE HAND MARKED TO BE LOT #9170806, WHILE ONE BAG WAS MARKED TO BE LOT #9078951. THE SAMPLES WERE VISUALLY EVALUATED THROUGH THE BAG WITH THE AID OF ILLUMINATED MAGNIFICATION. ALL THE SAMPLES EXHIBITED SIGNS OF LEAKAGE PAST STOPPER, WITH MOST SHOWING EITHER LIQUID OR DRIED RESIDUE PAST THE SECOND STOPPER RIB. NO FOREIGN MATTER WAS OBSERVED IN THE FLUID PATH NOR BETWEEN ANY OF THE STOPPER RIBS. NO STOPPER DEFECTS WERE OBSERVED. PRESSING AND PULLING ON THE PLUNGER ROD¿S THUMB REST IN SEVERAL OF THE SAMPLES, THE SEAL APPEARED TO REMAIN INTACT WITH NO ADDITIONAL LEAKAGE FORMING. NO MANUFACTURING DEFECTS WERE OBSERVED IN THE SAMPLES RECEIVED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A BD 10ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THE SYRINGES ARE LEAKING PAST THE STOPPER." 1 OF 8 COMPLAINTS.

    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 LEAKAGE OCCURRED DURING USE WITH A BD 10ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THE SYRINGES ARE LEAKING PAST THE STOPPER." 1 OF 8 COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57284 BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309605 9078951 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other