BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE FILL CHINA SP

    MDR report key: 19287494 · Received May 10, 2024

    Report

    Report Number
    1911916-2024-00347
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    April 29, 2024
    Report Date
    June 3, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    30382903065951
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 10169089 FOLLOW UP A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306595 AND LOT NUMBER 3142711. 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. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. OFF LABEL USE. PRODUCT IS SINGLE USE. AFTER EXPELLING THE SOLUTION IT SHOULD BE DISCARDED, NOT TO BE USED TO DRAW BLOOD. 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.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. H3 OTHER TEXT: SEE H10 MANUFACTURE NARRATIVE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED WHEN THE PATIENT WAS FLUSHED AND SEALED, THE CORE ROD AND PISTON WERE SEPARATED WHEN THE BLOOD WAS WITHDRAWN, AND THE FAMILY SAW THAT THEY HAD DOUBTS ABOUT THE QUALITY OF THE EQUIPMENT USED IN THE HOSPITAL, SO THEY REPLACED THE CATHETER IRRIGATOR WITH A NEW ONE, AND THEY WERE FULLY COMMUNICATED WITH AND UNDERSTOOD.

    Description of Event or Problem · 0

    WHEN THE PATIENT WAS FLUSHED AND SEALED, THE CORE ROD AND PISTON WERE SEPARATED WHEN THE BLOOD WAS WITHDRAWN, AND THE FAMILY SAW THAT THEY HAD DOUBTS ABOUT THE QUALITY OF THE EQUIPMENT USED IN THE HOSPITAL, SO THEY REPLACED THE CATHETER IRRIGATOR WITH A NEW ONE, AND THEY WERE FULLY COMMUNICATED WITH AND UNDERSTOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2499654 SYRINGE 10ML SALINE FILL CHINA SP SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 3142711 30382903065951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown