BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAP TIP SYR LL/LS STER LF PP BLUE SINGLE

    MDR report key: 11667867 · Received April 14, 2021

    Report

    Report Number
    1911916-2021-00314
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 5, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    KYX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A BOX OF SYRINGE TIP CAPS ARE CONTAMINATED WITH WHAT APPEARS TO BE DUST WITHIN THE SEALED PACKAGE. TO AID IN THE INVESTIGATION, SIX SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE SAMPLE CAME IN AN OPENED PACKAGING BLISTER, THE OTHER FIVE WERE IN SEALED PACKAGING BLISTERS. EACH SAMPLE WAS VISUALLY INSPECTED WITH A 10X MAGNIFICATION LENS. THE INNER SIDE OF THE PACKAGING TOP WEB HAS AN ADHERED BLACK INK PARTICLE. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. THIS DEFECT CAN OCCUR IF THE PRINTER HEAD WAS NOT CLEAN INDUCING THE SYMPTOM REPORTED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305819, LOT NUMBER 0202401. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE FOREIGN MATTER DEFECT. VERIFICATION OF CLEANLINESS OF THE PRINTERS WAS COMPLETED FINDING THEM SATISFACTORY. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BOX OF CAP TIP SYR LL/LS STER LF PP BLUE SINGLE HAD FOREIGN MATTER BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT A BOX OF SYRINGE TIP CAPS THAT APPEAR TO BE CONTAMINATED WITH WHAT APPEARS TO BE DUST WITHIN THE SEALED PACKAGE. VERBATIM: WE HAVE A BOX OF SYRINGE TIP CAPS THAT APPEAR TO BE CONTAMINATED WITH WHAT APPEARS TO BE DUST WITHIN THE SEALED PACKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560141 CAP TIP SYR LL/LS STER LF PP BLUE SINGLE LIQUID MEDICATION DISPENSER KYX BD MEDICAL (BD WEST) MEDICAL SURGICAL 0202401

    Patients

    Seq Age Sex Outcome Treatment
    1