BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 7266856 · Received February 13, 2018

    Report

    Report Number
    9610847-2018-00013
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    January 19, 2018
    Report Date
    April 11, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903096801
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE CUSTOMER RETURNED 100 REPRESENTATIVE SAMPLES OF CATALOG 309680. ONE CONVENIENCE TRAY ((B)(4) 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 (B)(4). REFERENCE THE ATTACHED COMPLAINT FORM THAT DETAILS WHICH BD (B)(4) LOTS WERE USED IN THE PACKAGING OF 309680 BD NOGALES BATCHES. THERE ARE NO REOCCURRING LOTS FROM THE MANUFACTURING PROCESS THAT LINKS THE LOTS IMPLICATED IN THE COMPLAINT. (B)(4). 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. NO COMPLAINTS HAVE BEEN FILED FOR LEAKAGE RELATED ISSUES FOR THE 7 LOTS LISTED IN THE COMPLAINTS. 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. 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. OVERALL, NO VISUAL DEFECTS WERE DETECTED ON THE SYRINGE. THE COMPLAINT LOTS WERE MANUFACTURED IN A >3 MONTH TIME PERIOD UNDER VARIOUS CONDITIONS USING COMPONENTS THAT WERE NOT COMMON TO EACH LOT. THE MOLDED COMPONENTS WERE MANUFACTURED WITH 9 DIFFERENT MOLDS. THE LEAKAGE IS RANDOM AND THERE ARE NO SPECIFIC TRENDS FOR MOLDS OR CAVITIES WITHIN THE MOLDS. BD DOES NOT BELIEVE THAT THE MANUFACTURING PROCESS IS RELATED TO THE REPORTED LEAKAGE ISSUES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 SEVERAL BD¿ PHARMACY CONVENIENCE TRAY LUER-LOK¿ STERILE SYRINGE(S) LEAKED DURING USE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111603 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY CONVENTIONAL SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN 30382903096801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other