BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® C&S TRANSFER STRAW KIT

    MDR report key: 8587243 · Received May 7, 2019

    Report

    Report Number
    1917413-2019-01441
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    April 24, 2019
    Report Date
    May 31, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JSM
    UDI-DI
    50382903649537
    PMA / PMN Number
    K024240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR INCORRECT PACKAGING WITH THE INCIDENT LOT WAS OBSERVED. EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED AND IT WAS OBSERVED THAT THE STRAW COMPONENTS WERE MISSING FROM THE PACKAGING. 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 SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR INCORRECT PACKAGING WITH THE INCIDENT LOT WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO A MANUFACTURING ISSUE. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL NO: 364953 BATCH NO: 8243846. IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® C&S TRANSFER STRAW KIT THE STRAWS ARE NOT INCLUDED IN THE PACKAGING AS THEY SHOULD BE AND IT MAKES THEM UNUSABLE. THERE WERE 25 OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE STRAWS ARE NOT INCLUDED IN THE PACKAGING AS THEY SHOULD BE AND IT MAKES THEM UNUSABLE. I HAVE SEVERAL ON MY DESK RIGHT NOW THAT WE HAVE SAVED TO SHOW SOMEONE THAT THEY ARE NOT PACKAGED CORRECTLY.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO: 364953, BATCH NO: 8243846. IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® C&S TRANSFER STRAW KIT THE STRAWS ARE NOT INCLUDED IN THE PACKAGING AS THEY SHOULD BE AND IT MAKES THEM UNUSABLE. THERE WERE 25 OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE STRAWS ARE NOT INCLUDED IN THE PACKAGING AS THEY SHOULD BE AND IT MAKES THEM UNUSABLE. I HAVE SEVERAL ON MY DESK RIGHT NOW THAT WE HAVE SAVED TO SHOW SOMEONE THAT THEY ARE NOT PACKAGED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378399 BD VACUTAINER® C&S TRANSFER STRAW KIT TRANSPORT CULTURE MEDIUM JSM BECTON, DICKINSON & CO. (BROKEN BOW) 8243846 50382903649537

    Patients

    Seq Age Sex Outcome Treatment
    1 Other