BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML SALINE FILL CHINA SP

    MDR report key: 12170774 · Received July 14, 2021

    Report

    Report Number
    1911916-2021-00681
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 29, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    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 306594 AND LOT NUMBER 0233724. 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. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS SUCH AS A VISION SYSTEM THAT INSPECTS 100% OF ALL PRODUCTS FOR CLOGGED NEEDLES. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. INVESTIGATION CONCLUSION: 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. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 5ML SALINE FILL CHINA SP BARREL WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2021, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR URINARY CALCULI. AT 16:13 ON (B)(6), AFTER THE PATIENTS INTRAVENOUS INFUSION, THE NURSING STAFF OPENED THE NEWLY PACKAGED FLUSH AND PREPARED TO SEAL THE TUBE FOR THE PATIENT, AND THE SEALING LIQUID WAS FOUND THE BARREL WAS DAMAGED AND COULD NOT BE USED NORMALLY, IMMEDIATELY REPLACED WITH A NEW ONE TO CHECK THAT THERE WAS NO QUALITY PROBLEM AND SEALED THE TUBE FOR THE PATIENT, CAUSING NO 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
    1067389 SYRINGE 5ML SALINE FILL CHINA SP SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0233724

    Patients

    Seq Age Sex Outcome Treatment
    1