BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 13502210 · Received February 9, 2022

    Report

    Report Number
    1920898-2022-00089
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    February 3, 2022
    Report Date
    March 14, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    JKA
    UDI-DI
    50382903673242
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPES ARE AS FOLLOWS. MEDICAL DEVICE TYPE: JKA / FPA. COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE CORRECTED: D2: MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. G2: MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. H6: INVESTIGATION SUMMARY: BD RECEIVED 4 SAMPLES FROM THE CUSTOMER IN SUPPORT OF THIS INVESTIGATION. AS THE DEVICES HAD BEEN OPENED, THEY ARE CONSIDERED CONTAMINATED AND CANNOT UNDERGO FUNCTIONAL TESTING. THEREFORE, THE DEVICES WILL BE INSPECTED FOR ANY POTENTIAL CAUSES OF OCCLUSION THAT WOULD RESULT IN LOW FLOW. THIS INCLUDES THE CANNULA, BASE OF THE NEEDLE HUB, AND LUER CONNECTION AND, THE CUSTOMER'S INDICATED FAILURE MODE FOR INSUFFICIENT BLOOD FLOW WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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 ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE INSUFFICIENT BLOOD FLOW. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE EXPERIENCED INSUFFICIENT BLOOD FLOW THROUGH THE DEVICE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT BLOOD COLLECTION SET DID NOT MEET SPECIFIED FLOW RATE. BLOOD COLLECTION SET DID NOT MEET SPECIFIED FLOW RATE. THE PRODUCT IS EXPECTED TO ACHIEVE A FLOW RATE OF AT LEAST 1.9 GRAMS IN 30 SECONDS. 3 SAMPLES WERE TESTED. 2 OUT THE 3 SAMPLES DID NOT MEET THE THRESHOLD. THERE WAS NO CUSTOMER, HCP OR PATIENT INVOLVED.

    Description of Event or Problem · 0

    MATERIAL NO. 367324, BATCH NO. 1147515. IT WAS REPORTED THAT BLOOD COLLECTION SET DID NOT MEET SPECIFIED FLOW RATE. BLOOD COLLECTION SET DID NOT MEET SPECIFIED FLOW RATE. THIS OCCURRED AT (B)(6) LAB. 23G PUSH BUTTON BLOOD COLLECTION SET WAS BEING TESTED (BENCHTOP TESTING) IN PREPARATION FOR AN UPCOMING TEST. THE PRODUCT IS EXPECTED TO ACHIEVE A FLOW RATE OF AT LEAST 1.9 GRAMS IN 30 SECONDS. 3 SAMPLES WERE TESTED. 2 OUT THE 3 SAMPLES DID NOT MEET THE THRESHOLD. THERE WAS NO CUSTOMER, HCP OR PATIENT INVOLVED. SAMPLES HAVE BEEN RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50249 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 367324 1147515 50382903673242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown