BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR

    MDR report key: 17043880 · Received June 1, 2023

    Report

    Report Number
    3003916417-2023-00116
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    May 3, 2023
    Report Date
    July 17, 2023
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL #: 360057; LOT/BATCH #: 2243567. BD HAD NOT RECEIVED SAMPLES BUT 1 PHOTO WAS RECEIVED FOR EVALUATION. THE RETURNED PHOTO SHOWED THE TUBE WITH THE CAP IN PLACE. ADDITIONALLY, (B)(4) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED AND NO DEFECTS WERE FOUND WITH THE RETAIN PRODUCT. 10 SAMPLES WERE TESTED WITH WATER AND THE CAP WAS REMOVED AND CLOSED AGAIN. IT WAS NOT POSSIBLE TO REPLICATE THE PROBLEM REPORTED BY THE CUSTOMER. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT WAS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS." .

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED THAT BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR ARRIVED WITH CAP LOOSE AND SEVERAL TIMES SAMPLE IS SPILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT AFTER VENIPUNCTURE, TRANSPORTED FROM ACQUISITION FACILITY BY ROLLER, THE TUBE ARRIVES WITH THE CAP LOOSE AND SEVERAL TIMES THE SAMPLE IS SPILLED. THERE WAS NO INJURY TO PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR ARRIVED WITH CAP LOOSE AND SEVERAL TIMES SAMPLE IS SPILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT AFTER VENIPUNCTURE, TRANSPORTED FROM ACQUISITION FACILITY BY ROLLER, THE TUBE ARRIVES WITH THE CAP LOOSE AND SEVERAL TIMES THE SAMPLE IS SPILLED. THERE WAS NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648357 BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 2243567

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown