BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD POSIFLUSH¿ SYRINGE

    MDR report key: 17130790 · Received June 14, 2023

    Report

    Report Number
    2243072-2023-01020
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 9, 2023
    Report Date
    May 23, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. E.1. INITIAL REPORTER PHONE #: (B)(6). INVESTIGATION SUMMARY: AS NO PHYSICAL SAMPLE, VALID PART NUMBER OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD POSIFLUSH¿ SYRINGE PACKING BAG WAS FOUND TO BE DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: BEFORE USING THE PRODUCT, THE PACKING BAG WAS FOUND TO BE DAMAGED AND AIR WAS LEAKED, SO THE NURSE IMMEDIATELY REPLACED THE PRE-FILLED CATHETER IRRIGATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956821 UNSPECIFIED BD POSIFLUSH¿ SYRINGE PISTON SYRINGE NGT BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown