BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE

    MDR report key: 8204642 · Received December 28, 2018

    Report

    Report Number
    9617032-2018-03287
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 4, 2018
    Report Date
    February 13, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679534
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR AIR BUBBLES IN THE GEL WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE RETENTION SAMPLES IDENTIFIED NO ISSUES WITH THE GEL APPEARANCE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR AIR BUBBLES IN THE GEL WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE RETENTION SAMPLES IDENTIFIED NO ISSUES WITH THE GEL APPEARANCE. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO A MANUFACTURING INCIDENT DURING GEL DISPENSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ II ADVANCE HAD AIR BUBBLES TRAPPED IN GEL NOTICED PRIOR TO USE.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8029626. MEDICAL DEVICE EXPIRATION DATE: 07/31/2019. DEVICE MANUFACTURE DATE: 01/29/2018. MEDICAL DEVICE LOT #: 8054715. MEDICAL DEVICE EXPIRATION DATE: 08/31/2019. DEVICE MANUFACTURE DATE: 02/23/2018. MEDICAL DEVICE LOT #: 7233897. MEDICAL DEVICE EXPIRATION DATE: 02/28/2019. DEVICE MANUFACTURE DATE: 08/21/2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ II ADVANCE HAD AIR BUBBLES TRAPPED IN GEL NOTICED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044026 BD VACUTAINER® SST¿ II ADVANCE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10 50382903679534

    Patients

    Seq Age Sex Outcome Treatment
    1 Other