BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD GP SERIES INFUSION SET

    MDR report key: 12913834 · Received December 1, 2021

    Report

    Report Number
    9616066-2021-52517
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 2, 2021
    Report Date
    January 4, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE LOT #: AN INVALID LOT # OF 1020560 WAS PROVIDED BY THE INITIAL REPORTER A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CORRECTION AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# WASN'T IN ERROR. THIS DEVICE IS MANUFACTURED IN A FACILITY THAT DOES NOT MANUFACTURE DEVICES FOR THE US MARKET. THESE DEVICES ARE SOLD OUTSIDE OF THE US AND ARE NOT SIMILAR TO BD DEVICES REGISTERED OR SOLD IN THE US. THEREFORE, THIS IS EXEMPT FROM US FDA REPORTING REQUIREMENTS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD GP SERIES INFUSION SET EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SET WAS REMOVED FROM AN UNTAMPERED PACK. ONCE THE FLUID FILLED THE LINE AND WAS PLACED INTO THE PUMP TO START THE NURSE NOTICED THERE WAS A LEAK FROM BELOW THE CHAMBER (WITH THE SPIKE AT THE TOP). A NEW SET WAS USED WITH A SHORT DELAY IN TREATMENT FOR THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD GP SERIES INFUSION SET EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SET WAS REMOVED FROM AN UNTAMPERED PACK. ONCE THE FLUID FILLED THE LINE AND WAS PLACED INTO THE PUMP TO START THE NURSE NOTICED THERE WAS A LEAK FROM BELOW THE CHAMBER (WITH THE SPIKE AT THE TOP). A NEW SET WAS USED WITH A SHORT DELAY IN TREATMENT FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805260 BD GP SERIES INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown