BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE FILL CHINA SP

    MDR report key: 11988472 · Received June 11, 2021

    Report

    Report Number
    1911916-2021-00554
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 1, 2021
    Report Date
    June 3, 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 306595 AND LOT NUMBER 0231132. 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. 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: FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML SALINE FILL CHINA SP PLUNGER ROD WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2021, THE PATIENT'S INFUSION ENDED, AND WHEN SEALING THE PICC FOR THE PATIENT, THE NURSE FOUND THAT THE TAIL FIN OF THE CORE OF THE 10ML PREFILLED SYRINGE WAS INCOMPLETE AND COULD NOT BE PUSHED. AFTER COMMUNICATION WITH THE NURSE, THE PATIENT EXPRESSED UNDERSTANDING AND REPLACED THE 10ML PREFILLED SYRINGE WITH THE SEALING TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883220 SYRINGE 10ML SALINE FILL CHINA SP SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 0231132

    Patients

    Seq Age Sex Outcome Treatment
    1