BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 15671547 · Received October 25, 2022

    Report

    Report Number
    1911916-2022-00588
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    September 30, 2022
    Report Date
    October 24, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065950
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THERE WERE ADVERSE REACTIONS AFTER USING THE SAME BATCH OF PRODUCTS. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. TO AID IN THE INVESTIGATION, ONE PHOTO THAT APPEARS TO BE A LETTER IN A FOREIGN LANGUAGE WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER: 306595, LOT NUMBER: 2081742. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND PROBABLE ROOT CAUSE COULD NOT BE OFFERED. 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 PATIENTS EXPERIENCED ANAPHYLACTIC SHOCK AFTER THE BD POSIFLUSH¿ NORMAL SALINE SYRINGES WERE USED TO FLUSH THE TUBING. ADDITIONALLY, OTHER PATIENTS SUFFERED ADVERSE GASTROINTESTINAL REACTIONS AFTER THE SYRINGES WERE USED ON THEM, AS WELL AS NAUSEA AND VOMITING. NO FURTHER INFORMATION WAS PROVIDED. THERE WERE A TOTAL OF 480 OCCURRENCES REPORTED FOR THESE ADVERSE EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "PATIENTS WITH PICC TUBES OCCURRED SYMPTOMS OF ANAPHYLACTIC SHOCK AFTER USING THE COMPLAINT PRODUCT TO FLUSH THE TUBES, WHICH IMPROVED AFTER EMERGENCY RESCUE. PATIENTS WITH PICC & PORT HAD GASTROINTESTINAL ADVERSE REACTIONS AFTER USING THE SAME BATCH OF COMPLAINT PRODUCTS, COMPLAINING OF ODOR, NAUSEA AND VOMITING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2720087 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 2081742 00382903065950

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other