BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 7433026 · Received April 16, 2018

    Report

    Report Number
    9610847-2018-00103
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Date of Event
    February 3, 2018
    Report Date
    May 8, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903096801
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTGATION SUMMARY: THE CUSTOMER RETURNED 100 REPRESENTATIVE SAMPLES OF CATALOG 309680. ONE CONVENIENCE TRAY (20 SYRINGES/EA) WAS RECEIVED FROM THE FOLLOWING BATCHES: 7184872, 7242754, 7214744, 7270964, AND 7184875. 309680 IS PACKAGED IN BD NOGALES USING BULK SYRINGES MANUFACTURED IN BD COLUMBUS WEST. SAMPLES CONTAINED A MIXTURE OF COMPONENTS FROM THE FOLLOWING MOLDS ¿ N2, N3, N8, N25, N26 (BARREL MOLDS) AND N9, N10, N27, N30 (PLUNGER ROD MOLDS). SAMPLES WERE VISUALLY EVALUATED AND NO DEFECTS WERE NOTED. THE SYRINGES WERE LEAK TESTED AT THE 60 ML MARKING PER IT21 REV 07. OF THE 100 SYRINGES RETURNED, 41 DID NOT LEAK, 42 LEAKED PAST THE FIRST RIB, AND 17 LEAKED PAST THE SECOND RIB. A BATCH REVIEW OF THE COMPLAINT LOTS (INCLUDING ALL OF THE AFFECTED COLUMBUS WEST LOTS) WAS CONDUCTED. NO ISSUES AFFECTING LEAKAGE WERE RECORDED DURING THE MANUFACTURING PROCESS. DIMENSIONAL MEASUREMENTS AND FUNCTIONAL TESTING PERFORMED AT THE TIME OF MANUFACTURING WAS ACCEPTABLE. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE THE COMPLAINT IS NOT CONFIRMED BASED ON THE USE AND CONDITIONS COMMUNICATED BY THE CUSTOMER. THE CUSTOMER REPORTED LEAKAGE FROM OTHER SIZES AND BRANDS OF SYRINGES DURING THE SAME TIME PERIOD AND THE SYRINGES MAY HAVE BEEN SHIPPED IN -30° C WEATHER. THE SYRINGES WERE ALSO USED IN AN OFF-LABEL MANNER VIA STORING MEDICATION. PRODUCT WITHIN SPECIFICATION? YES? NO?

    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 WAS FOUND ON A BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY BETWEEN THE "FIRST AND SECOND RIBS" OF THE STOPPER. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277426 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY CONVENTIONAL SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7270964 30382903096801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other