BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FLASHBACK BLOOD COLLECTION NEEDLES 21G X 1"

    MDR report key: 7002295 · Received November 5, 2017

    Report

    Report Number
    8041187-2017-00172
    Event Type
    Malfunction
    Date Received
    November 5, 2017
    Date of Event
    October 13, 2017
    Report Date
    October 30, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). INVESTIGATION: INVESTIGATION SUMMARY: DHR REVIEW: REVIEWED LOT MASTER FOR AN PART 8079958 BATCH 6230002, 6230004 AND 6264222. NO SIMILAR DEFECT FOUND DURING THE OUTGOING AND IN-PROCESS INSPECTION FOR FBN ASSEMBLY. INVESTIGATION CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE COULD NOT BE DETERMINED AS THERE IS NO RETURNED SAMPLE FOR FM IDENTIFICATION. THERE IS NO SIMILAR DEFECT IN DHR REVIEW. THE COMPLAINT WILL BE RE-OPENED IF A SAMPLE IS RECEIVED FOR INVESTIGATION. ROOT CAUSE CANNOT BE DETERMINED WITHOUT A RETURNED SAMPLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS FOUND ON THE CANNULA OF A BD FLASHBACK BLOOD COLLECTION NEEDLES 21G X 1" BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781630 BD FLASHBACK BLOOD COLLECTION NEEDLES 21G X 1" BLOOD COLLECTION SET JKA BECTON DICKINSON MEDICAL (SINGAPORE) 6264174

    Patients

    Seq Age Sex Outcome Treatment
    1 Other