BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL VLV ADPT(STAND ALONE)

    MDR report key: 10989254 · Received December 10, 2020

    Report

    Report Number
    9616066-2020-20554
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 16, 2020
    Report Date
    January 7, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES WERE RECEIVED FOR INVESTIGATION. CUSTOMER HAS INDICATED THAT THEY HAVE EXPERIENCED LEAKAGE AND CRACKING OF THE SMARTSITE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE AS NO SAMPLE WAS RECEIVED FOR INVESTIGATION. WITHOUT A SAMPLE TO EXAMINE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1017153 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LL VLV ADPT(STAND ALONE) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 2 OF 3: THE CUSTOMER RECENTLY BEEN HAVING PROBLEMS REPORTED OF THE BD SMART SITE LEAKING AND OR CRACKING. (B)(6) 2020 - THE SMART SITE IS LEAKING AND FEELING LOOSE ON THE BROVIAC LINE HUB, I HAVE ASSESSED THIS DIRECTLY AND THE REF: (B)(4), LOT: 1017153, EXP: 2023-04 WAS THE BATCH THAT THIS HAS OCCURRED SEVERAL TIMES, NO CRACK SEEN.

    Additional Manufacturer Narrative · 1

    (B)(6)/NO 510K THIS IS AN INTERNATIONAL CODE - THE MODEL#/CATALOG# IDENTIFIED IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS 2000E. THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT. K960280. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LL VLV ADPT(STAND ALONE) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 2 OF 3. THE CUSTOMER RECENTLY BEEN HAVING PROBLEMS REPORTED OF THE BD SMART SITE LEAKING AND OR CRACKING. (B)(6) 2020 - THE SMART SITE IS LEAKING AND FEELING LOOSE ON THE BROVIAC LINE HUB, I HAVE ASSESSED THIS DIRECTLY AND THE REF: 2000E7D, LOT: 1017153, EXP 2023-04 WAS THE BATCH THAT THIS HAS OCCURRED SEVERAL TIMES, NO CRACK SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446923 LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 1017153

    Patients

    Seq Age Sex Outcome Treatment
    1