BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® C&S TRANSFER STRAW KIT

    MDR report key: 8837784 · Received July 29, 2019

    Report

    Report Number
    1917413-2019-01822
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Date of Event
    June 27, 2019
    Report Date
    August 8, 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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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. FURTHER FOLLOW UP WAS CONDUCTED WITH THE CUSTOMER, AND EDUCATIONAL MATERIALS WERE SENT REGARDING PROPER URINE SPECIMEN COLLECTION FOR THIS PRODUCT. THE CUSTOMER RELAYED TO BD TECH SERVICES THAT THE ISSUE WAS NOW INFREQUENT (ABOUT TWICE A MONTH). ADDITIONALLY, THE CUSTOMER INDICATED THEY WOULD SHARE THE URINE EDUCATIONAL MATERIALS WITH THE STAFF. BD WILL CONTINUE TO MONITOR FOR ADDITIONAL COMPLAINTS AND EMERGING TRENDS. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. 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

    IT WAS REPORTED THAT BD VACUTAINER® C&S TRANSFER STRAW KIT WAS GIVING ERRONEOUS RESULTS. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 364953 BATCH NO: 9031733 IT WAS REPORTED THE CUSTOMER WAS HAVING PROBLEMS WITH INTERFERING GROWTH ON THE MACCONKEY AGAR. (URINE TUBE) BAP LOT # 532112, READING >200, MAC LOT # 532128, READING 18.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 · 1

    IT WAS REPORTED THAT BD VACUTAINER® C&S TRANSFER STRAW KIT WAS GIVING ERRONEOUS RESULTS. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 364953, BATCH NO: 9031733. IT WAS REPORTED THE CUSTOMER WAS HAVING PROBLEMS WITH INTERFERING GROWTH ON THE MACCONKEY AGAR (URINE TUBE). BAP LOT # 532112, READING >200, MAC LOT # 532128, READING 18.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633451 BD VACUTAINER® C&S TRANSFER STRAW KIT TRANSPORT CULTURE MEDIUM JSM BECTON, DICKINSON & CO. (BROKEN BOW) 9031733 50382903649537

    Patients

    Seq Age Sex Outcome Treatment
    1 Other