BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTRAMEDIC¿ LUER-STUB ADAPTER

    MDR report key: 17312947 · Received July 12, 2023

    Report

    Report Number
    1911916-2023-00477
    Event Type
    Malfunction
    Date Received
    July 12, 2023
    Date of Event
    June 15, 2023
    Report Date
    June 16, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FPA
    PMA / PMN Number
    K142527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER STATE: ADDRESS INFORMATION WAS NOT ABLE TO BE OBTAINED, THEREFORE, CA WAS USED AS A PLACE HOLDER BASED OFF USER FACILITY. H.6. INVESTIGATION SUMMARY: IT WAS REPORTED THE RUBBER FROM VIAL IS GETTING STUCK IN THE NEEDLE. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS TWO NEEDLE ASSEMBLIES WITH NO PLASTIC SHIELDS. ONE IS CONNECTED TO A SYRINGE AND THE OTHER NEEDLE IS NEXT TO THE SYRINGE. THE NEEDLE ASSEMBLY CONNECTED TO THE SYRINGE HAS A STRING OF MATERIAL AT THE NEEDLE TIP THAT APPEARS TO BE THE SAME COLOR AS THE VIAL RUBBER STOPPER. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 427563, LOT 1012139. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO 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 PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD INTRAMEDIC¿ LUER-STUB ADAPTER "CORING" OCCURRED AND "RUBBER" FOREIGN MATTER WAS STUCK IN THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RUBBER FROM VIAL IS GETTING STUCK IN THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209934 BD INTRAMEDIC¿ LUER-STUB ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA BD MEDICAL (BD WEST) MEDICAL SURGICAL 1012139

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown