BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 11122093 · Received January 6, 2021

    Report

    Report Number
    1911916-2021-00003
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 8, 2020
    Report Date
    January 2, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K161552 ((B)(4)). PMA / 510(K)#: K141311 ((B)(4)). 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 THAT THE BD POSIFLUSH" NORMAL SALINE SYRINGE PLUNGER WAS "IMMOVABLE" DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE IDENTIFIED ISSUES WITH LOT # 0230895 WHERE THE PLUNGER IS IMMOVABLE ON, I.E., WILL NOT FLUSH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21770 BD POSIFLUSH NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306546 0230895 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1