BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH SYRINGE

    MDR report key: 11548127 · Received March 22, 2021

    Report

    Report Number
    1911916-2021-00233
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    February 8, 2021
    Report Date
    March 17, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306594 AND LOT NUMBER 0141768. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. 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" SYRINGE BARREL WAS FOUND DAMAGED WHEN REMOVING IT FROM THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "ON (B)(6) 2021, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO POSTERIOR CIRCULATION ISCHEMIA. AT 08:00 ON (B)(6), THE NURSING STAFF USED THE FULLY PACKAGED FLUSH TO PREPARE THE INFUSION TUBE AND FOUND THAT THE DISPOSABLE FLUSH WAS DAMAGED. IT CAN NOT USE,AND IMMEDIATELY REPLACE THE DISPOSABLE FLUSH TO CHECK THAT THERE IS NO QUALITY PROBLEM AND FLUSH THE TUBE FOR THE PATIENT WITHOUT CAUSING HARM TO THE PATIENT, AND NO OTHER ADVERSE EVENTS OCCURRED DURING THE ENTIRE EVENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437884 BD POSIFLUSH SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 0141768

    Patients

    Seq Age Sex Outcome Treatment
    1