BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 18297215 · Received December 8, 2023

    Report

    Report Number
    1024879-2023-00887
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    September 27, 2023
    Report Date
    April 3, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FPA
    UDI-DI
    50382903673426
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY : MATERIAL #: 367342. LOT/BATCH #: 3132308. BD HAD NOT RECEIVED SAMPLES, BUT TWO 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THEY SHOW THE UNIT PACKAGING CONFIRMING THE LOT NUMBER. ADDITIONALLY, THIRTY 30 RETAIN SAMPLES WERE SUBJECTED TO A DRAW TEST TO ASSESS TUBE PUSH OFF DURING DRAW. NINE (9) OF THE SAMPLES FAILED TESTING AS THERE WAS TUBE PUSH OFF DURING DRAW. THEREFORE, THIS COMPLAINT CAN BE CONFIRMED BASED ON RETAIN SAMPLE TESTING RESULTS. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE TUBE PUSH OFF. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.5. PMA / 510(K)#: K220212. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE USER COULD NOT INSERT THE TUBE FULLY INTO THE ONE-USE HOLDER AND FORM A SEAL. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE USER COULD NOT INSERT THE TUBE FULLY INTO THE ONE-USE HOLDER AND FORM A SEAL. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825272 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE FPA BECTON, DICKINSON & CO., (BD) 3132308 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown