BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 7948560 · Received October 9, 2018

    Report

    Report Number
    1213809-2018-00659
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    September 18, 2018
    Report Date
    October 23, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903097020
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    TWO OPEN 3ML TRAYS WERE RECEIVED AND CONFIRMED TO BE FROM BATCH #8143675 (P/N 309702). THE SAMPLES WERE VISUALLY EVALUATED. THE SAMPLES WERE FOUND TO HAVE MULTIPLE LOOSE BLACK FOREIGN MATTER PARTICLES INSIDE THE TRAYS. THE PARTICLES OBSERVED ARE LEVEL 1 AND LEVEL 2 WHICH IS AN ACCEPTABLE CONDITION 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. ROOT CAUSE FOR FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS.

    Additional Manufacturer Narrative · 0

    TWO OPEN 3ML TRAYS WERE RECEIVED AND CONFIRMED TO BE FROM BATCH #8143675 (P/N 309702). THE SAMPLES WERE VISUALLY EVALUATED. THE SAMPLES WERE FOUND TO HAVE MULTIPLE LOOSE BLACK FOREIGN MATTER PARTICLES INSIDE THE TRAYS. THE PARTICLES OBSERVED ARE LEVEL 1 AND LEVEL 2 WHICH IS AN ACCEPTABLE CONDITION 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. ROOT CAUSE FOR FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD LUER-LOK SYRINGE PACKAGE CONTAINED A LOT OF DUST AND SPECKS IN IT. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD LUER-LOK SYRINGE PACKAGE CONTAINED A LOT OF DUST AND SPECKS IN IT. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    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 A BD LUER-LOK¿ SYRINGE PACKAGE CONTAINED A LOT OF DUST AND SPECKS IN IT. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786774 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8143675 30382903097020

    Patients

    Seq Age Sex Outcome Treatment
    1 Other