BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH 68 I.U. PLUS BLOOD COLLECTION TUBES

    MDR report key: 20137747 · Received September 4, 2024

    Report

    Report Number
    9617032-2024-01387
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 9, 2024
    Report Date
    September 24, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903684960
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 11-SEP-2024. INVESTIGATION SUMMARY: MATERIAL #: 368496. LOT/BATCH #: 4081460; 4022413; 4036899. BD RECEIVED 6 SAMPLES OF LOT 4081460, NON-BD ADAPTORS, AND 3 PHOTOS FOR INVESTIGATION. EVALUATION OF THE PHOTOGRAPHS INDICATED CAP/STOPPER ASSEMBLY STUCK IN A NON-BD HOLDER. BD DOES NOT MAKE ANY CLAIMS THAT THE DEVICES ARE COMPATIBLE. THEREFORE THE INDICATED FAILURE MODE FOR STOPPER PULLOUT WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH 10 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO STOPPER PULLOUT AS ALL SAMPLES MET SPECIFICATIONS. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE STOPPER PULLOUT. BD WAS NOT ABLE TO IDENTIFY A DEFINITIVE 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

    B.3. DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 4022413 D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025 D4. UNIQUE IDENTIFIER (UDI) (B)(4) H4. DEVICE MANUFACTURE DATE: 22-JAN2024 D4. MEDICAL DEVICE LOT#: 4036899 D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025 D4. UNIQUE IDENTIFIER (UDI) #: (B)(4) H4. DEVICE MANUFACTURE DATE: 05-FEB-2024 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 WHEN USING THE BD VACUTAINER® LH 68 I.U. PLUS BLOOD COLLECTION TUBES, THE STOPPER PULLED OUT WHILE PROCESSING SAMPLES ON AN UNSPECIFIED NUMBER OF TUBES. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LH 68 I.U. PLUS BLOOD COLLECTION TUBES, THE STOPPER PULLED OUT WHILE PROCESSING SAMPLES ON AN UNSPECIFIED NUMBER OF TUBES. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833570 BD VACUTAINER® LH 68 I.U. PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 4081460 00382903684960

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown