BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA MULTI-PATIENT DISPOSABLE SET

    MDR report key: 6182683 · Received December 16, 2016

    Report

    Report Number
    2520313-2016-00083
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    December 1, 2016
    Report Date
    January 24, 2017
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K050456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED MULTI-PATIENT DISPOSABLE SET (MPAT) SYRINGE, LOT NUMBER 154502. VISUAL EXAMINATION FOUND NO EVIDENCE OF THE ALLEGED PARTICULATE. HOWEVER, EXAMINATION OF THE PHOTOGRAPHS PROVIDED BY THE CUSTOMER DID CONFIRM THE PRESENCE OF A SMALL, GRAY PARTICLE ON THE TIP OF THE CONTRAST SPIKE OF THE MPAT. AS THE PARTICLE COULD NOT BE CONFIRMED UPON RECEIPT OF THE PRODUCT, DIMENSIONAL EXAMINATION AND PARTICLE CHARACTERIZATION COULD NOT BE PERFORMED OR DETERMINED.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR THAT WAS SUBMITTED ON (B)(6) 2016 CONTAINED AN INCORRECT LOT/BATCH NUMBER. THE CORRECT LOT/BATCH NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON THE LIMITED INFORMATION, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE UNKNOWN PARTICLE AT THIS TIME; HOWEVER, THE PRODUCT IS SCHEDULED TO RETURN TO BAYER FOR A FULL EVALUATION. ONCE THE EVALUATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE AVANTA MULTI-PATIENT STERILE DISPOSABLE SET (MPAT) AND UPON INSPECTION, THEY SAW A FOREIGN BODY ON THE SALINE SPIKE. THE CUSTOMER ELECTED NOT TO USE THE TUBING. NO INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831799 AVANTA MULTI-PATIENT DISPOSABLE SET ANGIOGRAPHIC TUBING SET DXT BAYER MEDICAL CARE, INC. 84194867 754502

    Patients

    Seq Age Sex Outcome Treatment
    1