BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE

    MDR report key: 10645398 · Received October 7, 2020

    Report

    Report Number
    8041187-2020-00647
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 16, 2020
    Report Date
    October 8, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED 2 USED SAMPLES AND 1 PHOTO FROM THE CUSTOMER FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR INSUFFICIENT BLOOD FLOW WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, BOTH CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR INSUFFICIENT BLOOD FLOW WITH THE INCIDENT LOT WAS NOT OBSERVED. INSPECTION FOR CLOGGED NEEDLE AND SLEEVE FUNCTION TEST COULD NOT BE DONE AS THE RETURNED SAMPLES HAVE ALREADY BEEN USED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH A BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE THERE WAS INSUFFICIENT BLOOD FLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN USING THE FBN, IT FOUND THAT THE FBN HAS INSUFFICIENT BLOOD FLOW ISSUE.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE WITH A BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE THERE WAS INSUFFICIENT BLOOD FLOW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN USING THE FBN, IT FOUND THAT THE FBN HAS INSUFFICIENT BLOOD FLOW ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111250 BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE BLOOD COLLECTION NEEDLE JKA BECTON DICKINSON MEDICAL (SINGAPORE) 9352884

    Patients

    Seq Age Sex Outcome Treatment
    1 Other