BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CTAD BLOOD COLLECTION TUBE

    MDR report key: 9151907 · Received October 3, 2019

    Report

    Report Number
    9617032-2019-01127
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    September 18, 2019
    Report Date
    October 4, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS OBSERVED, HOWEVER THE PHOTOS DID NOT IDENTIFY A SPECIFIC PRODUCT ISSUE. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® CTAD BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING UNDERFILL DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: I WOULD LIKE TO INFORM YOU OF A PROBLEM WITH THE FILLING OF CTAD TUBES (PRODUCT REFERENCE 367562, LOT 9081676, EX 03/2020). INDEED, WE USE THESE TUBES FOR DIALYSIS UNITS THAT COLLECT DIRECTLY FROM A CENTRAL LINE. WE HAVE CARRIED OUT SEVERAL TESTS (CHANGE OF LOT, OR SAMPLING EQUIPMENT), THE TUBES ONLY FILL TO A MAXIMUM OF 1/4. THE BLACK NOTCH AT THE MID-TUBE IS NEVER REACHED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® CTAD BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING UNDERFILL DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: I WOULD LIKE TO INFORM YOU OF A PROBLEM WITH THE FILLING OF CTAD TUBES (PRODUCT REFERENCE 367562 LOT 9081676 EX 03/2020). INDEED, WE USE THESE TUBES FOR DIALYSIS UNITS THAT COLLECT DIRECTLY FROM A CENTRAL LINE. WE HAVE CARRIED OUT SEVERAL TESTS (CHANGE OF LOT, OR SAMPLING EQUIPMENT), THE TUBES ONLY FILL TO A MAXIMUM OF 1/4. THE BLACK NOTCH AT THE MID-TUBE IS NEVER REACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948299 BD VACUTAINER® CTAD BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 9081676

    Patients

    Seq Age Sex Outcome Treatment
    1 Other