BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® URINE COLLECTION CUP

    MDR report key: 14939627 · Received July 6, 2022

    Report

    Report Number
    9617032-2022-00613
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Date of Event
    June 3, 2022
    Report Date
    June 15, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MAT: 364941. LOT: 2073478, 2066601. BD RECEIVED PHOTOGRAPH FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE PHOTO WAS EVALUATED AND THE CUSTOMERS INDICATED FAILURE MODE OF MISSING LABEL WAS OBSERVED. THE INDICATED FAILURE MODE WAS NOT OBSERVED DURING THE SAME EVALUATION. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE OF MISSING LABEL FROM THE PHOTO PROVIDED HOWEVER, BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. BD RECEIVED PHOTOGRAPH FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT SHOWING MISSING LABEL. NO SEPARATED LIDS WERE OBSERVED. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE FROM THE PHOTO PROVIDED - MISSING LABEL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2073478. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2022-03-14. MEDICAL DEVICE LOT #: 2066601. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2022-03-07.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® URINE COLLECTION CUP HAD LABELED DEFECT AND LACK OF CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WE ARE COMING BACK TO YOU ABOUT THE NON-CONFORMITIES OBSERVED THESE LAST DAYS CONCERNING THE BD URINE COLLECTION JAR REFERENCE (B)(4). YOU WILL FIND ATTACHED A PICTURE OF THE FIRST DEFECT (LABEL DEFECT), PLEASE NOTE THAT THIS PICTURE HAS BEEN TAKEN ON ANOTHER BATCH (N°2066601), IN ORDER TO UNDERLINE THE RECURRENCE OF THE DYSFUNCTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2672136 BD VACUTAINER® URINE COLLECTION CUP SPECIMEN TRANSPORT AND STORAGE CONTAINER JKA BECTON, DICKINSON AND COMPANY (BD) 2066601

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown