BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER® SST¿ TUBES

    MDR report key: 15330230 · Received August 31, 2022

    Report

    Report Number
    2618282-2022-00051
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    July 26, 2022
    Report Date
    September 9, 2022
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    PMA / PMN Number
    K991702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 44 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO STOPPER FUNCTION (LEAKAGE) AS ALL SAMPLES MET SPECIFICATIONS. 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 FUNCTION (LEAKAGE). BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MICROTAINER® SST¿ TUBES, THE DEVICE EXPERIENCED SAMPLE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ON (B)(6) 2022, LETSGETCHECKED (LGC) COMPLAINTS TEAM INFORMED LGC QUALITY TEAM THAT A CUSTOMER HAS REPORTED ON (B)(6) 2022 THAT THE TUBE FROM THEIR SAMPLE COLLECTION KIT HAD A LEAKAGE DURING TRANSPORT AFTER BLOOD COLLECTION. IT¿S BEEN HAPPENED MULTIPLE TIMES. LGC HAVE LOGGED THIS COMPLAINT AS CN-2022-945. QUANTITY AFFECTED: 1 COMPLIANT WAS REPORTED FROM THE UK. LGC HAVE MADE ATTEMPTS TO CONTACT THE CUSTOMER IN RELATION TO THE RETURN OF THE MICROTAINERS BLOOD TUBE BUT THEY WERE NON-RESPONSIVE, SO COULDN T PROVIDE RETURN FOR INVESTIGATION. THIS NOTIFICATION IS INTENDED TO NOTIFY BD OF ISSUES OF ¿BLOOD TUBE LEAKAGE¿, SO BD CAN TRACK THESE ISSUES AND TRACK TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD MICROTAINER® SST¿ TUBES, THE DEVICE EXPERIENCED SAMPLE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ON 03-AUG-2022, LETSGETCHECKED (LGC) COMPLAINTS TEAM INFORMED LGC QUALITY TEAM THAT A CUSTOMER HAS REPORTED ON 26-JUL-2022 THAT THE TUBE FROM THEIR SAMPLE COLLECTION KIT HAD A LEAKAGE DURING TRANSPORT AFTER BLOOD COLLECTION. IT¿S BEEN HAPPENED MULTIPLE TIMES. LGC HAVE LOGGED THIS COMPLAINT AS (B)(4). QUANTITY AFFECTED: 1 COMPLIANT WAS REPORTED FROM THE UK. LGC HAVE MADE ATTEMPTS TO CONTACT THE CUSTOMER IN RELATION TO THE RETURN OF THE MICROTAINERS BLOOD TUBE BUT THEY WERE NON-RESPONSIVE, SO COULDN¿T PROVIDE RETURN FOR INVESTIGATION. THIS NOTIFICATION IS INTENDED TO NOTIFY BD OF ISSUES OF ¿BLOOD TUBE LEAKAGE¿, SO BD CAN TRACK THESE ISSUES AND TRACK TRENDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773022 BD MICROTAINER® SST¿ TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 2028809

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown