BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE

    MDR report key: 10517785 · Received September 10, 2020

    Report

    Report Number
    8041187-2020-00556
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Date of Event
    August 21, 2020
    Report Date
    October 26, 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 HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR MISSING LABEL WITH THE INCIDENT LOT WAS OBSERVED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LABELS WERE MISSING WITH A BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE. THIS OCCURRED ON 2 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN PREPARING USING THE FBN, IT FOUND THAT 2EA FBN'S NEEDLE BODY HAVE NO LABEL.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LABELS WERE MISSING WITH A BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE. THIS OCCURRED ON 2 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: WHEN PREPARING USING THE FBN, IT FOUND THAT 2EA FBN'S NEEDLE BODY HAVE NO LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983627 BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE BLOOD COLLECTION NEEDLE JKA BECTON DICKINSON MEDICAL (SINGAPORE) 9298315

    Patients

    Seq Age Sex Outcome Treatment
    1 Other