BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ SYRINGE

    MDR report key: 15224221 · Received August 15, 2022

    Report

    Report Number
    1911916-2022-00426
    Event Type
    Malfunction
    Date Received
    August 15, 2022
    Date of Event
    July 1, 2022
    Report Date
    August 8, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306594 AND LOT NUMBER 1201833. 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. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. 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 · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ SYRINGE INNER PACKAGE WAS MISSING, THUS AFFECTING STERILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN THE PATIENT NEEDED TO SEAL THE TUBE AFTER THE INFUSION, THE CARTON PACKAGE OF PREFLUSHING SYRINGE WAS OPENED AND FOUND NO INNER PACKAGING, SO IT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254472 BD POSIFLUSH¿ SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 1201833

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown