BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K3 EDTA / APROTININ TUBE

    MDR report key: 15218436 · Received August 12, 2022

    Report

    Report Number
    9617032-2022-00760
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    July 20, 2022
    Report Date
    August 8, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD DID NOT RECEIVE SAMPLES OR PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. VISUAL EXAMINATION OF THE 100 RETAINED SAMPLES FROM EACH OF THE IMPLICATED LOT NUMBERS: 1312775; 2112168 DID NOT IDENTIFY ANY INSTANCES OF DAMAGED TUBES. 10 RETAINED TUBES FROM EACH LOT NUMBER WERE TAKEN AND DRAWN WITH WATER. THEY WERE CENTRIFUGED AT 1300G FOR 10 MINUTES. NONE OF THE 20 TUBES BROKE, AND EXAMINATION OF THEIR RIMS POST CENTRIFUGATION, REVEALED NO SIGNS OF CRACKING. NONE OF THE CAPS SEPARATED DURING THE EXERCISE. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE NO SAMPLES WERE RETURNED IN SUPPORT OF THIS COMPLAINT AND THE DEFECTS WAS NOT EVIDENT IN THE EVALUATION OF THE RETAINED SAMPLES, ALSO REVIEW OF THE DHRS SHOWED NO INDICATION OF THE ALLEGED DEFECTS. 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. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1312775; MEDICAL DEVICE EXPIRATION DATE: 2022-11-30; DEVICE MANUFACTURE DATE: 2021-11-08. MEDICAL DEVICE LOT #: 2112168; MEDICAL DEVICE EXPIRATION DATE: 2023-04-30; DEVICE MANUFACTURE DATE: 2022-04-22.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K3 EDTA / APROTININ TUBE THERE WAS CRACKED TUBE AND STOPPER CREEP OUT OR LOOSE CLOSURE. THE CRACKED TUBE EVENT OCCURRED 3 TIMES. THE STOPPER CREEP OUT EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE CUSTOMER REPORTED THE FOLLOWING TWO ISSUES THAT HAD BEEN FREQUENTLY OCCURRING: (1) AFTER CENTRIFUGATION, A CRACK ON THE WALL OF TUBE WAS FOUND. (2) DURING CENTRIFUGATION, THE CAP WAS SEPARATED. THESE ISSUES CAN BE ATTRIBUTED NOT TO PRODUCT QUALITY BUT TO CENTRIFUGE TUBE RACK OR COMPATIBILITY WITH CENTRIFUGE MACHINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995902 BD VACUTAINER® K3 EDTA / APROTININ TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown