BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    MDR report key: 13457341 · Received February 4, 2022

    Report

    Report Number
    1024879-2022-00062
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 7, 2022
    Report Date
    February 8, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1201461. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2021-07-20. MEDICAL DEVICE LOT #: 1201462. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2021-07-20. 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

    INVESTIGATION SUMMARY: NO CUSTOMER SAMPLES OR PHOTOS WERE RECEIVED FOR REVIEW AND ANALYSIS. THEREFORE, 10 RETENTION SAMPLES FOR BATCH 1201461 WERE SUBJECTED TO A TUBE PUSH OFF TEST WITH 5 OF 10 SAMPLES FAILING THE TEST. THEREFORE, THIS DEFECT IS CONFIRMED. ADDITIONALLY, 10 RETENTION SAMPLES FOR BATCH 1201462 WERE SUBJECTED TO A TUBE PUSH OF TEST WITH 6 OF 10 SAMPLES FAILING THE TEST. THEREFORE, THIS DEFECT IS CONFIRMED. AS NO CUSTOMER SAMPLES OR PHOTOS WERE RECEIVED THE SCOPE OF THIS INVESTIGATION IS LIMITED. BD IS ABLE TO CONFIRM THE CUSTOMER¿S REPORTED FAILURE OF TUBE PUSH OFF FROM THE RETENTION SAMPLE TESTING. THE ROOT CAUSE OF THE TUBE PUSH-OFF ISSUE IS EXCESS LUBRICATION ON THE NON PATIENT CANNULA. SEPARATELY, 10 RETENTION SAMPLES FROM EACH BATCH (1201461 AND 1201462) WERE SUBJECTED TO A FUNCTIONAL TESTING AS WELL AS A VISUAL FOR SPLATTER DURING THE TEST AND THE CUSTOMER'S INDICATED FAILURE MODE OF SPLATTER WAS NOT OBSERVED AS ALL SAMPLES PASSED THE TEST WITH NO DEFECTS OBSERVED. BD WAS UNABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE BASED ON RETENTION SAMPLE TESTING RESULTS. BASED ON A REVIEW OF BATCH RECORDS, NO ROOT CAUSE FROM MANUFACTURING WAS IDENTIFIED AS A CONTRIBUTOR. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE DEVICE EXPERIENCED TUBE PUSH OFF, CAUSING BLOOD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT TUBES POPPING OFF BUTTERFLY BEFORE FULL OCCURRED AND SPLATTERING BLOOD WHEN THE SAFETY WAS ENGAGED. ANOTHER INCIDENCE HAPPENED ON (B)(6) 2022 WHERE THE BUTTERFLIES WERE SPLATTERING BLOOD WHEN THE SAFETY WAS ENGAGED. THESE WERE ALSO FROM LOT # 1201462. I DON¿T BELIEVE ANY BLOOD SPLATTERED ON THE TEAM MEMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, THE DEVICE EXPERIENCED TUBE PUSH OFF, CAUSING BLOOD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT TUBES POPPING OFF BUTTERFLY BEFORE FULL OCCURRED AND SPLATTERING BLOOD WHEN THE SAFETY WAS ENGAGED. ANOTHER INCIDENCE HAPPENED ON (B)(6) 2022 WHERE THE BUTTERFLIES WERE SPLATTERING BLOOD WHEN THE SAFETY WAS ENGAGED. THESE WERE ALSO FROM LOT # 1201462. I DON¿T BELIEVE ANY BLOOD SPLATTERED ON THE TEAM MEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649667 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown