BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML SALINE FILL CHINA SP

    MDR report key: 23066317 · Received September 16, 2025

    Report

    Report Number
    1911916-2025-00640
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 23, 2025
    Report Date
    September 24, 2025
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306594 AND LOT NUMBER 4113410. 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML SALINE FILL CHINA SP CAP FELL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING THE APPLICATION OF AN INDWELLING NEEDLE FOR A PATIENT, WHEN SEALING THE CATHETER AFTER COMPLETING THE INFUSION, IT WAS DISCOVERED THAT THE CONE CAP OF THE PRE-FILLED CATHETER FLUSHING DEVICE HAD COME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2680093 BD SYRINGE 5ML SALINE FILL CHINA SP SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 4113410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown