BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML SALINE FILL CHINA SP

    MDR report key: 19351125 · Received May 20, 2024

    Report

    Report Number
    2243072-2024-00635
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 23, 2024
    Report Date
    May 31, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    30382903065944
    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

    FOLLOW UP MDR FOR CORRECTION. FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS NOTED THAT THE MATERIAL NUMBER WAS PROVIDED AND WAS NOT UNKNOWN AS PREVIOUSLY REPORTED. SECTION D UPDATED WITH THE CORRECT MATERIAL NUMBER AND MEDICAL DEVICE BRAND NAME SECTION G UPDATED WITH 510K.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. IN THIS MDR, BD FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AS THE MANUFACTURING SITE IS UNKNOWN. D. THE LOT NUMBER 3090844 PROVIDED HAS NOT BEEN VERIFIED; NO REPORTED MATERIAL NUMBER.

    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 3090844. 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

    MATERIAL NUMBER PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNDEFINED BD 5ML PREFILLED SYRINGE TIP COVER FELL OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2024, THE CHILD WAS ADMITTED TO THE HOSPITAL DUE TO BRONCHOPNEUMONIA, AND THE NEEDLE PLUG FELL OFF WHEN THE INFUSION TUBE WAS SEALED, AND THE NEW PREFILLED CATHETER IRRIGATOR WAS IMMEDIATELY REPLACED FOR SEALING, WHICH DID NOT CAUSE ADVERSE CONSEQUENCES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024, THE CHILD WAS ADMITTED TO THE HOSPITAL DUE TO BRONCHOPNEUMONIA, AND THE NEEDLE PLUG FELL OFF WHEN THE INFUSION TUBE WAS SEALED, AND THE NEW PREFILLED CATHETER IRRIGATOR WAS IMMEDIATELY REPLACED FOR SEALING, WHICH DID NOT CAUSE ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147538 SYRINGE 5ML SALINE FILL CHINA SP SALINE VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 3090844 30382903065944

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown