BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE PMS PLH 13X75 3.0 SLBL LIM CE

    MDR report key: 10309753 · Received July 22, 2020

    Report

    Report Number
    9617032-2020-00592
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    June 29, 2020
    Report Date
    August 7, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR EVALUATION. ADDITIONALLY, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE THE TUBE PMS PLH 13X75 3.0 SLBL LIM CE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿TUBE DOES NOT ¿FILL UP¿.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 DURING USE THE TUBE PMS PLH 13X75 3.0 SLBL LIM CE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿TUBE DOES NOT ¿FILL UP¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775929 TUBE PMS PLH 13X75 3.0 SLBL LIM CE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other