BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE FILL CHINA SP

    MDR report key: 19608235 · Received June 25, 2024

    Report

    Report Number
    1911916-2024-00452
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    June 11, 2024
    Report Date
    July 9, 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

    FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS DETERMINED THAT THE COMPLAINT WAS SUBMITTED IN ERROR. THERE WAS NO IDENTIFIED DEFECT OR MALFUNCTION. THIS MDR WILL BE VOID AND THE COMPLAINT CANCELLED.

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306595 AND LOT NUMBER 3142708. 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.

    Additional Manufacturer Narrative · 0

    FOLLOW UP MDR FOR CORRECTION. FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS NOTED THAT AN INCORRECT VERBIAGE WAS USED IN SECTION H10. CORRECTED VERBIAGE: 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

    (B)(6) 2024 10:00 DURING A PATIENT'S IV INFUSION, USING A PRE-FILLED CATHETER FLOSSER, WHEN GIVING THE PATIENT A RETRACTABLE DEEP VEIN RETRACTION, THE ACTUATOR PORTION OF THE CATHETER FLOSSER DISENGAGED FROM ITS PISTON, INCREASING THE PATIENT'S NERVOUSNESS, 10:02 A NEW CATHETER FLOSSER REPLACEMENT WAS GIVEN TO RETRACT THE RETRACTION, AND THE OPERATION WENT SMOOTHLY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. ON (B)(6) 2024 10:00 DURING A PATIENT'S IV INFUSION, USING A PRE-FILLED CATHETER FLOSSER, WHEN GIVING THE PATIENT A RETRACTABLE DEEP VEIN RETRACTION, THE ACTUATOR PORTION OF THE CATHETER FLOSSER DISENGAGED FROM ITS PISTON, INCREASING THE PATIENT'S NERVOUSNESS, 10:02 A NEW CATHETER FLOSSER REPLACEMENT WAS GIVEN TO RETRACT THE RETRACTION, AND THE OPERATION WENT SMOOTHLY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696905 SYRINGE 10ML SALINE FILL CHINA SP SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 3142708 30382903065951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown