BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML SALINE FILL CHINA SP

    MDR report key: 18759505 · Received February 22, 2024

    Report

    Report Number
    1911916-2024-00133
    Event Type
    Malfunction
    Date Received
    February 22, 2024
    Date of Event
    February 5, 2024
    Report Date
    March 2, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    30382903065937
    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

    (B)(4) FOLLOW UP. IT WAS REPORTED THE PREFILLED CATHETER FLOSSER LEAKED FROM THE PACKAGE AND WAS UNUSABLE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A PREFILLED SYRINGE IN ITS PACKAGING FLOW WRAP. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306593, LOT 2153547. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WITHOUT THE ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A FRACTURE, AND ON (B)(6) 2024, THE CHARGE NURSE TREATED THE PATIENT WITH INTRAVENOUS FLUIDS AS PRESCRIBED, AND AT THE END OF THE PROCEDURE, WHILE USING A PREFILLED CATHETER FLOSSER FOR INDWELLING NEEDLE SEALING, HE FOUND THAT THE PREFILLED CATHETER FLOSSER LEAKED FROM THE PACKAGE AND WAS UNUSABLE, AND IT WAS IMMEDIATELY REPLACED WITHOUT HARM TO THE PATIENT.

    Description of Event or Problem · 0

    THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A FRACTURE, AND ON (B)(6) 2024, THE CHARGE NURSE TREATED THE PATIENT WITH INTRAVENOUS FLUIDS AS PRESCRIBED, AND AT THE END OF THE PROCEDURE, WHILE USING A PREFILLED CATHETER FLOSSER FOR INDWELLING NEEDLE SEALING, HE FOUND THAT THE PREFILLED CATHETER FLOSSER LEAKED FROM THE PACKAGE AND WAS UNUSABLE, AND IT WAS IMMEDIATELY REPLACED WITHOUT HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444951 SYRINGE 3ML SALINE FILL CHINA SP SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 2153547 30382903065937

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown