BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 16141608 · Received January 11, 2023

    Report

    Report Number
    1024879-2023-00018
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 16, 2022
    Report Date
    January 24, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2022-12-29. H.6. INVESTIGATION SUMMARY: BD RECEIVED THIRTEEN (13) SAMPLES AND TWO (2) PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR GEL AIR BUBBLES WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR GEL AIR BUBBLES WITH THE INCIDENT LOT WAS OBSERVED. IN ADDITION, ONE OF THE CUSTOMER SAMPLES HAD FM WITHIN THE GEL. BD IS UNABLE TO COMPLETE FTIR TESTING OF THE FM DUE TO THE FM BEING WITHIN THE GEL. BASED ON A REVIEW OF BATCH RECORDS AND THE INVESTIGATION RESULTS, A ROOT CAUSE OF THE GEL AIR BUBBLES WAS DUE TO INADEQUATE PURGING DURING GEL DRUM CHANGE. AS A CORRECTIVE ACTION THE AWARENESS WAS MADE TO THE ASSOCIATES DURING GEL DRUM CHANGE. BASED ON A REVIEW OF BATCH RECORDS AND THE INVESTIGATION RESULTS, NO ROOT CAUSE FROM THE MANUFACTURING PROCESS HAS BEEN IDENTIFIED AS A CONTRIBUTOR TO THE FM. THIS COMPLAINT HAS BEEN CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS AIR BUBBLES IN THE GEL. THIS EVENT OCCURRED 14 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WERE "BUBBLES OR HOLES IN THE GEL OF TUBES 367986 LOT#: 2173183."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE THERE WAS AIR BUBBLES IN THE GEL. THIS EVENT OCCURRED 14 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WERE "BUBBLES OR HOLES IN THE GEL OF TUBES 367986 LOT#: 2173183."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192154 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 2173183 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown