BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE

    MDR report key: 10693538 · Received October 16, 2020

    Report

    Report Number
    8041187-2020-00675
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    September 27, 2020
    Report Date
    October 22, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 10/5/2020. H.6. INVESTIGATION: BD RECEIVED 51 SAMPLES FROM THE CUSTOMER FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR SLEEVE LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. THE SLEEVE RECOVERED THE CANNULA ON ALL 51 SAMPLES. 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. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF SLEEVE LEAKAGE THROUGH A CORRECTIVE AND PREVENTIVE ACTION (CAPA#1800001).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE EXPERIENCED POOR SLEEVE FUNCTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BLOOD COLLECTION ROOM OF THE USER FACILITY REPORTED THAT DURING THE FBN BLOOD COLLECTION PROCESS AGAIN THIS MORNING, THE TAIL END RUBBER SLEEVE FAILED TO REBOUND NORMALLY AND CAUSED BLOOD LEAKAGE. THE BATCH NUMBER OF THE PROBLEM WAS 0051334, WHICH OCCURRED IN THE SECOND TUBE BLOOD COLLECTION. WEARING GLOVES, THE BLOOD DID NOT TOUCH THE NURSE'S SKIN. THERE HAVE BEEN MULTIPLE BLOOD LEAKS IN THIS DEPARTMENT OF THE HOSPITAL.

    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 BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE EXPERIENCED POOR SLEEVE FUNCTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE BLOOD COLLECTION ROOM OF THE USER FACILITY REPORTED THAT DURING THE FBN BLOOD COLLECTION PROCESS AGAIN THIS MORNING, THE TAIL END RUBBER SLEEVE FAILED TO REBOUND NORMALLY AND CAUSED BLOOD LEAKAGE. THE BATCH NUMBER OF THE PROBLEM WAS 0051334, WHICH OCCURRED IN THE SECOND TUBE BLOOD COLLECTION. WEARING GLOVES, THE BLOOD DID NOT TOUCH THE NURSE'S SKIN. THERE HAVE BEEN MULTIPLE BLOOD LEAKS IN THIS DEPARTMENT OF THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159172 BD VACUTAINER FLASHBACK BLOOD COLLECTION NEEDLE BLOOD COLLECTION NEEDLE JKA BECTON DICKINSON MEDICAL (SINGAPORE) 0051334

    Patients

    Seq Age Sex Outcome Treatment
    1 Other