BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) 10.8MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 20328679 · Received September 27, 2024

    Report

    Report Number
    9617032-2024-01509
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 19, 2024
    Report Date
    September 18, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. D4. UNIQUE IDENTIFIER (UDI) #:(B)(4). H4. DEVICE MANUFACTURE DATE: UNKNOWN. D4. MEDICAL DEVICE LOT#: 3080530 D4. MEDICAL DEVICE EXPIRATION DATE: 31-08-2024 D4. UNIQUE IDENTIFIER (UDI) #:(B)(4) H4. DEVICE MANUFACTURE DATE: 21-03-2023. D4. MEDICAL DEVICE LOT#: 3191557 D4. MEDICAL DEVICE EXPIRATION DATE: 31-12-2024 D4. UNIQUE IDENTIFIER (UDI) #:(B)(4) H4. DEVICE MANUFACTURE DATE: 10-07-2023. H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT TWO (2) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR CRACKED TUBE WAS OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM EACH OF THE LOT NUMBERS PROVIDED WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF CRACKED TUBE WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF CRACKED TUBE BASED ON THE PHOTO ANALYSIS. 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. INVESTIGATION SUMMARY: LOT#: UNKNOWN BD HAD NOT RECEIVED SAMPLES, BUT TWO (2) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR CRACKED TUBE WAS OBSERVED. BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF CRACKED TUBE BASED ON PHOTO ANALYSIS. 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."

    Description of Event or Problem · 0

    REPORT 9 OF 13 IT WAS REPORTED WHILE USING BD VACUTAINER® K2E (EDTA) 10.8MG PLUS BLOOD COLLECTION TUBES, THERE WERE THIRTY-FIVE (35) TUBES WITH CRACKS TOWARD THE BASE OF THE TUBE RESULTING IN SEEPAGE OR LEAKAGE. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962380 BD VACUTAINER® K2E (EDTA) 10.8MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown