BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE CIT PLH 13X75 2.7 109 USI L-MG CE

    MDR report key: 11369699 · Received February 23, 2021

    Report

    Report Number
    9617032-2021-00167
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    February 4, 2021
    Report Date
    March 5, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 20 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING 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. 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 TUBE CIT PLH 13X75 2.7 109 USI L-MG CE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "DURING USE, THE TUBES DO NOT FILL PROPERLY."

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER EMAIL: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE TUBE CIT PLH 13X75 2.7 109 USI L-MG CE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "DURING USE, THE TUBES DO NOT FILL PROPERLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266484 TUBE CIT PLH 13X75 2.7 109 USI L-MG CE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 0232884

    Patients

    Seq Age Sex Outcome Treatment
    1