BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE FILL CHINA SP

    MDR report key: 19974425 · Received August 13, 2024

    Report

    Report Number
    1911916-2024-00589
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 19, 2024
    Report Date
    September 30, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    30382903065951
    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

    (B)(4) FOLLOW UP: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306595 AND LOT NUMBER 3355640. 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

    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'S INTRAVENOUS TREATMENT CLINIC FOUND THAT THE OUTER EDGE OF THE UNOPENED FOLICILI SYRINGE WAS BROKEN, WHICH DID NOT AFFECT USE, BUT THE HAND MAY BE INJURED. AMONG THE REMAINING FLESIES, (B)(4) WERE FOUND. 2024-8-27 UPDATE INFORMATION COMMENT(SENT):1. THE CUSTOMER REPORTED SEVEN OCCURRENCES; ARE THEY ALL RELATED TO A SINGLE EVENT OR DO THEY PERTAIN TO DIFFERENT EVENTS? IF THEY ARE DISTINCT, PLEASE PROVIDE THE DATES OF THE OTHER EVENTS. 2. HAVE THE (B)(4) OCCURRENCES INVOLVED A SINGLE PATIENT OR MULTIPLE PATIENTS? COMMENT(REC): ACCORDING TO THE CUSTOMER, SEVERAL FAULTY FLUSHERS WERE FOUND IN (B)(4) BOXES. HOWEVER, THE SAMPLES WITH PROBLEMS WERE NOT CONSISTENT WITH THE BATCH IN THE COMPLAINT, SO A NEW COMPLAINT WAS MADE. THE EXPRESS NUMBER SF (B)(4) HAS BEEN SENT. THE FEEDBACK IS THE SAME PROBLEM.

    Description of Event or Problem · 0

    THE PATIENT'S INTRAVENOUS TREATMENT CLINIC FOUND THAT THE OUTER EDGE OF THE UNOPENED FOLICILI SYRINGE WAS BROKEN, WHICH DID NOT AFFECT USE, BUT THE HAND MAY BE INJURED. AMONG THE REMAINING FLESIES, 7 WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894687 SYRINGE 10ML SALINE FILL CHINA SP SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 3355640 30382903065951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown