BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18055765 · Received November 2, 2023

    Report

    Report Number
    9614033-2023-00124
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 9, 2023
    Report Date
    January 27, 2024
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903033102
    PMA / PMN Number
    K151766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, CLIENT IS OBSERVED HOLDING PLUNGER WITH THE STOPPER ASSEMBLED AND AN OILY SUBSTANCE. THERE IS A SUBSTANCE IN THE STOPPER WHICH COULD BE SILICONE; HOWEVER, SINCE THERE IS NO PHYSICAL SAMPLE, THE NATURE OF THE SUBSTANCE PRESENT IN THE PRODUCT REPORTED BY THE CLIENT CANNOT BE CONFIRMED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 3012144 , NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. RESULTS WERE REVIEWED FOR LOT 3012144 AND FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WAS AT THE (B)(6) CENTER AND WE CAME ACROSS SOME SYRINGES THAT SEEMED TO HAVE AN UNUSUAL AMOUNT OF LUBRICANT ON THEM. ASSUMING THIS IS SOME SORT OF SILICONE. SEEMED TO BE WITH 20 ML SYRINGES LOT #3012144 WE OPENED MULTIPLES, AND THEY WERE ALL VERY SIMILAR. WE COMPARED IT TO A 30 ML SYRINGE. "

    Description of Event or Problem · 0

    ADDITIONAL INFO RECEIVED ARE YOU ABLE TO PROVIDE DATE OF INCIDENT? (B)(6) 23 HOW MANY PIECES THAT YOU HAVE FOUND TO HAVE THE SAME ISSUE? APPROXIMATELY 40 SYRINGES CAN YOU PLEASE CONFIRM THAT THERE WAS NO PATIENT IMPACT AND/OR INJURY? YES NO PATIENT IMPACT, PHARMACIST CAUGHT PRIOR TO ANY PATIENTS RECEIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928004 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 3012144 00382903033102

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown