BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISPENSING PIN

    MDR report key: 17140215 · Received June 15, 2023

    Report

    Report Number
    9616066-2023-01192
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 19, 2023
    Report Date
    May 23, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203020114
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, H.4. DEVICE MANUFACTURE DATE: UNKNOWN; H.6. INVESTIGATION SUMMARY: A 2201-0006 SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION; FURTHERMORE THE LOT NUMBER OF THE COMPLAINT SAMPLE WAS REPORTED UNKNOWN. THE FEEDBACK PROVIDED BY THE CUSTOMER SUGGESTS DIFFICULTY WAS EXPERIENCED WHEN ATTEMPTING TO DISCONNECT THE VIAL ACCESS PIN FROM A SYRINGE FOLLOWING USE; FURTHER INFORMATION SUGGESTS THIS IS DUE TO THE LACK OF CONTOURING AT THE BASE OF THE PIN. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS AN ISOLATED FEEDBACK WITH NO FURTHER REPORTS OF THIS NATURE AGAINST THE 2201-0006 PRODUCT OVER THE PAST 12 MONTHS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD DISPENSING PIN IT WAS DIFFICULT TO DISCONNECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS DIFFICULT TO REMOVE THE SYRINGE ON THE VIAL ACCESS PIN AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494511 BD DISPENSING PIN INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN 07613203020114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown