BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE NON STERILE 50ML LL

    MDR report key: 18535028 · Received January 18, 2024

    Report

    Report Number
    3003152976-2024-00027
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    January 3, 2024
    Report Date
    February 28, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903002233
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 300223 AND LOT NUMBER 2212082. 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. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    I WOULD LIKE TO INFORM YOU THAT OUR QUALITY DEPARTMENT HAS RECEIVED A CUSTOMER COMPLAINT ABOUT YOUR PRODUCT "300223/ SERINGUE 50ML LLM NS BULK" ATTACHED IS THE FORM WITH THE NECESSARY INFORMATION. NO PHOTO OR SAMPLE ACCOMPANYING THIS RC. TO FOLLOW UP ON THE DESCRIPTION OF THE DEFECT (IN THE FORM): THE MULTI AD IS A NON-DIRECT INFUSION LINE OR A MULTI-AD DIFFUSER TRANSFER LINE. ONE SIDE OF THE TUBING IS A FIRING PIN/PERFORATOR THAT IS STUCK INTO A POCKET OF SUSPENDED "LIQUID." THE OTHER SIDE OF THE MULTI AD CONSISTS OF A DOUBLE TIP (1 FEMALE AND 1 MALE). THE SYRINGE IS CONNECTED TO THE FEMALE TIP. THE BREAKAGE IS NOTICED AT THE TIME OF CONNECTION OF THE SYRINGE AND THE MULTI AD; KNOWING THAT THE THREAD OF THE LATTER IS NO LONGER DAMAGED, THIS IS THE 1STUSE. NO RISK TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830608 SYRINGE NON STERILE 50ML LL SYRINGE, PISTON FMF BECTON DICKINSON 2212082 50382903002233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown