BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML SALINE FILL CHINA SP

    MDR report key: 20824924 · Received December 2, 2024

    Report

    Report Number
    1911916-2024-00860
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 25, 2024
    Report Date
    December 14, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    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 PRE-FILLED LIQUID LEAKED OUT CAUSING THE OUTER PACKAGING OF FIVE BOXES OF PRODUCT TO BE SOAKED AND DAMAGED. TO AID IN THE INVESTIGATION, FIVE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A PACKAGING SHELF BOX WITH DAMAGE THAT APPEARS TO BE FROM EXPOSURE TO HUMIDITY. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306595, LOT 4152255. 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. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTOS SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER OF PACKAGE DAMAGED IS CONFIRMED, BUT A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    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.

    Description of Event or Problem · 0

    THE WAREHOUSE PURCHASING TEACHER REPORTED THAT AFTER UNPACKING, IT WAS FOUND THAT THE PRE-FILLED LIQUID HAD LEAKED OUT, CAUSING THE OUTER PACKAGING OF 5 BOXES OF PRODUCTS TO BE SOAKED AND DAMAGED. THE NUMBER OF AFFECTED PRODUCTS WAS 150. THE SAMPLES COULD NOT BE RETURNED. PHOTOS CAN BE PROVIDED. A COMPLAINT REPLY LETTER IS REQUIRED, A COMPLAINT RECEIPT LETTER IS REQUIRED, AND A GREEN CLAIM IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95194 SYRINGE 10ML SALINE FILL CHINA SP SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 4152255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown