BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 17995589 · Received October 24, 2023

    Report

    Report Number
    9617032-2023-01529
    Event Type
    Malfunction
    Date Received
    October 24, 2023
    Date of Event
    October 2, 2023
    Report Date
    November 2, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903684977
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO STOPPER POP OFF AS ALL SAMPLES MET SPECIFICATIONS. 10 RETAINED SAMPLES FROM LOT NUMBER 3163205, WERE DRAWN WITH WATER, CENTRIFUGED AT 1300G 10MIN. NONE OF THE CAP/STOPPER ASSEMBLIES POPPED OFF. 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 STOPPER POP OFF. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    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 AFTER CENTRIFUGATION OF BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES, STOPPER WAS RELEASED FROM TUBES. NO PATIENT IMPACT REPORTED. WHEN CENTRIFUGATION OF TUBES ENDED, CUSTOMER SAW THAT STOPPER WAS RELEASED FROM TUBES. I HAVE ASKED THE CUSTOMER FOR MORE INFORMATION. NO IMPACT REGARDING PATIENT OR STAFF. NO PHOTOS. PROTECTIONS GLOVES WAS USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER CENTRIFUGATION OF BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES, STOPPER WAS RELEASED FROM TUBES. NO PATIENT IMPACT REPORTED. WHEN CENTRIFUGATION OF TUBES ENDED, CUSTOMER SAW THAT STOPPER WAS RELEASED FROM TUBES. I HAVE ASKED THE CUSTOMER FOR MORE INFORMATION. NO IMPACT REGARDING PATIENT OR STAFF. NO PHOTOS. PROTECTIONS GLOVES WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744238 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3163205 00382903684977

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown