BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 12520219 · Received September 23, 2021

    Report

    Report Number
    2243072-2021-02377
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    August 27, 2021
    Report Date
    September 9, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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)). DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD POSIFLUSH" NORMAL SALINE SYRINGE PLUNGER WAS DIFFICULT TO MOVE DURING THE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FLUSH, RESISTANCE WHEN ADVANCING PLUNGER". "THE PATIENT HAD A MIDLINE AND I WAS ATTEMPTING TO FLUSH AND IT WAS VERY DIFFICULT TO FLUSH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415390 BD POSIFLUSH NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 306546 UNKNOWN 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1