BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® Z (NO ADDITIVE) PLUS URINE TUBE

    MDR report key: 8832308 · Received July 26, 2019

    Report

    Report Number
    9617032-2019-00846
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 10, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JSM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 IT WAS OBSERVED THAT THE BOTTOM OF THE TUBE WAS CRACKED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOTS 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, IT WAS OBSERVED THAT THE BOTTOM OF THE TUBE WAS CRACKED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. 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 THE BD VACUTAINER® Z (NO ADDITIVE) PLUS URINE TUBE LEAKED THROUGH THE BASE AND ONTO THE URINE ANALYZER AFTER USE WHILE UNCAPPING IT. LOT #'S 9063852 AND 8348691 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "LOSS OF URINE THROUGH THE BASE OF THE TUBE AFTER UNCAPPING IT, LOSS OF THE PATIENT'S URINE SAMPLE, HAVING TO MAKE A NEW REQUEST." "THE URINE LEAKS OUT OVER THE ANALIZER, BEING NEEDED TO CLEAN IT UP."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9063852, MEDICAL DEVICE EXPIRATION DATE: 2020-02-29, DEVICE MANUFACTURE DATE: 2019-03-04. MEDICAL DEVICE LOT #: 8348691, MEDICAL DEVICE EXPIRATION DATE: 2019-12-31, DEVICE MANUFACTURE DATE: 2018-12-14. DEVICE EVALUATED BY MFR: 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

    IT WAS REPORTED THAT THE BD VACUTAINER® Z (NO ADDITIVE) PLUS URINE TUBE LEAKED THROUGH THE BASE AND ONTO THE URINE ANALYZER AFTER USE WHILE UNCAPPING IT. LOT #'S 9063852 AND 8348691 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LOSS OF URINE THROUGH THE BASE OF THE TUBE AFTER UNCAPPING IT, LOSS OF THE PATIENT'S URINE SAMPLE, HAVING TO MAKE A NEW REQUEST." "THE URINE LEAKS OUT OVER THE ANALYZER, BEING NEEDED TO CLEAN IT UP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623823 BD VACUTAINER® Z (NO ADDITIVE) PLUS URINE TUBE TRANSPORT CULTURE MEDIUM JSM BECTON, DICKINSON AND COMPANY (BD) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other