BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 8798545 · Received July 17, 2019

    Report

    Report Number
    1213809-2019-00748
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    June 21, 2019
    Report Date
    August 19, 2019
    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
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE PHOTO OF A CLOSE-UP OF AN OPENED AND EMPTY CONVENIENCE TRAY IN A PLASTIC BAG WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A BLACK FOREIGN MATTER FIBER PRESENT IN THE TRAY. IT APPEARED TO BE A STRAND OF HAIR, BUT IT WAS UNCLEAR IF THE HAIR WAS ATTACHED TO THE BAG OR THE WALL OF THE TRAY FROM THE PHOTO PROVIDED. THE FOREIGN MATTER WAS LARGER THAN LEVEL 3 IN SIZE AND WAS REJECTABLE PER PRODUCT SPECIFICATION. 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. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE SYRINGE 10ML LL TIP BULK CONVENIENCE PAK WAS FOUND WITH FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED A HAIR WAS FOUND IN A BOX OF SYRINGES RESULTING IN DESTRUCTION OF A TOTAL OF 63 SYRINGES. VERBATIM: (B)(6) 2019 - A HAIR WAS FOUND IN A BOX OF SYRINGES OF LOT 9002961, CAUSING US TO DESTROY A TOTAL OF 63 SYRINGES. THE DESTRUCTION FOR THIS PRODUCT ALONE WILL COST (B)(6), NOT TO MENTION USED API AND OTHER INGREDIENTS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE SYRINGE 10ML LL TIP BULK CONVENIENCE PAK WAS FOUND WITH FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED A HAIR WAS FOUND IN A BOX OF SYRINGES RESULTING IN DESTRUCTION OF A TOTAL OF 63 SYRINGES. VERBATIM: (B)(6) 2019 - A HAIR WAS FOUND IN A BOX OF SYRINGES OF LOT 9002961, CAUSING US TO DESTROY A TOTAL OF 63 SYRINGES. THE DESTRUCTION FOR THIS PRODUCT ALONE WILL COST (B)(6), NOT TO MENTION USED API AND OTHER INGREDIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594076 SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9002961 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other