BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD POSIFLUSH NORMAL SALINE SYRINGE

    MDR report key: 12140095 · Received July 8, 2021

    Report

    Report Number
    1911916-2021-00652
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    April 6, 2021
    Report Date
    June 23, 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

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306595 AND LOT NUMBER 0231039. 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. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THIS PRODUCT AND SYMPTOM. WITH NO SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS SUFFERING FROM CEREBRAL INFARCTION. ON (B)(6) 2021, THE NURSE IN THE HOSPITAL COULD NOT EXHAUST THE AIR USING THE FLUSH AND COULD NOT SEAL THE TUBE. AFTER DISCOVERY, THE SAME BATCH OF NEW PRODUCTS FROM THE FACTORY WAS REPLACED IN TIME, AND THE PATIENT CONTINUED TO BE TREATED WITH INFUSION. THERE WAS NO EFFECT ON PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030084 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE PREFILLED SALINE SYRINGE NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 0231039

    Patients

    Seq Age Sex Outcome Treatment
    1