BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® FX 5MG 4MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 17716292 · Received September 8, 2023

    Report

    Report Number
    1917413-2023-00889
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    August 18, 2023
    Report Date
    September 15, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    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

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD DID NOT RECEIVE SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL 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 OF UNDERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® FX 5MG 4MG PLUS BLOOD COLLECTION TUBES CUSTOMER REPORTS OF UNDERFILLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ON (B)(6) WE RECEIVED AN EMAIL FROM THE EMERGENCY DEPARTMENT ALERTING US TO A PROBLEM WITH THE FILLING OF BARRICOR TUBES. APPARENTLY, THE TUBES WERE NOT FILLING TO THE MARK. THE EXPIRY DATE IS NOVEMBER 2023, BATCH NUMBER: 2192117. HOWEVER, THIS IS NOT THE ONLY DEPARTMENT TO SEND US INSUFFICIENTLY FILLED TUBES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® FX 5MG 4MG PLUS BLOOD COLLECTION TUBES CUSTOMER REPORTS OF UNDERFILLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ON 29/06 WE RECEIVED AN EMAIL FROM THE EMERGENCY DEPARTMENT ALERTING US TO A PROBLEM WITH THE FILLING OF BARRICOR TUBES. APPARENTLY, THE TUBES WERE NOT FILLING TO THE MARK. THE EXPIRY DATE IS NOVEMBER 2023, BATCH NUMBER: 2192117. HOWEVER, THIS IS NOT THE ONLY DEPARTMENT TO SEND US INSUFFICIENTLY FILLED TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243632 BD VACUTAINER® FX 5MG 4MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 2166094

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown