BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE LUER-LOK¿ CONVENIENCE TRAY

    MDR report key: 7455643 · Received April 24, 2018

    Report

    Report Number
    9610847-2018-00093
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    April 3, 2018
    Report Date
    September 26, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: TWO ADDITIONAL LOT NUMBERS WERE PROVIDED FOR THE COMPLAINT. THE INFORMATION FOR THE INCLUDED LOT NUMBERS IS AS FOLLOWS. D.4. MEDICAL DEVICE LOT #¿: 7214981. D.4. MEDICAL DEVICE EXPIRATION DATE: 09/30/2022. H.4. DEVICE MANUFACTURE DATE: 10/19/2017. D.4. MEDICAL DEVICE LOT #¿: 7173788. D.4. MEDICAL DEVICE EXPIRATION DATE: 09/30/2022. H.4. DEVICE MANUFACTURE DATE: 10/19/2017. INVESTIGATION SUMMARY: BD RECEIVED TWENTY 60CC SYRINGES FROM LOTS 7173788 AND 7214981 FOR EVALUATION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED SAMPLES AND DETERMINED THAT NINETEEN OF THE SAMPLES HAD NO DEFECTS WHILE THE LAST ONE HAD A BUBBLE AND FOREIGN MATTER EMBEDDED IN IT. BASED ON THE VISUAL INSPECTION OF THE LAST SAMPLE THE ENGINEER WAS ABLE TO VERIFY THE REPORTED ISSUE OF FOREIGN MATTER. BUBBLES CAN OCCUR WHEN THE VENTS IN THE MOLD ARE BLOCKED. THIS DOESN'T ALLOW FOR PROPER VENTING OF THE BUILT UP GASES AND THEY COLLECT IN THE MOLD CREATING POCKETS. NEXT, FOREIGN MATTER CAN BECOME EMBEDDED IN THE SYRINGES DURING THE STARTUP PROCESS. LEFTOVER RESIN ON THE MOLDING PRESS CAN BECOME DEGRADED AND BREAK LOOSE CAUSING IT TO BECOME MOLDED INTO THE COMPONENTS. NORMALLY THE PRESS IS RAN AND FLUSHED UNTIL FOREIGN MATTER IS NO LONGER DETECTED ON THE PRESS. THIS APPEARED TO HAVE BEEN AN ISOLATED INCIDENT AS THIS WAS THE FIRST REPORTED CASE OF FOREIGN MATTER ASSOCIATED WITH THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED ZERO DEFECTS FOUND DURING PRODUCTION. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ SYRINGE LUER-LOK¿ CONVENIENCE TRAY HAD A WHITE STREAK AND BLACK SPOT NEAR THE TIP OF THE SYRINGE. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    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.

    Additional Manufacturer Narrative · 1

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ SYRINGE LUER-LOK¿ CONVENIENCE TRAY HAD A WHITE STREAK AND BLACK SPOT NEAR THE TIP OF THE SYRINGE. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SYRINGE LUER-LOK CONVENIENCE TRAY HAD A WHITE STREAK AND BLACK SPOT NEAR THE TIP OF THE SYRINGE. FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298860 BD¿ SYRINGE LUER-LOK¿ CONVENIENCE TRAY SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7270965

    Patients

    Seq Age Sex Outcome Treatment
    1 Other