BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXGUARD EXTENSION SET

    MDR report key: 16500577 · Received March 8, 2023

    Report

    Report Number
    9616066-2023-00352
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 10, 2023
    Report Date
    May 19, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403236259
    PMA / PMN Number
    K051499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 03-MAR-2023. H6: INVESTIGATION SUMMARY SIX SAMPLES WERE RETURNED FOR INVESTIGATION BY THE CUSTOMER. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SETS WERE ATTACHED TO A 10 ML BD SYRINGE FILLED WITH WATER AND WERE UNABLE TO BE FLUSHED. VISUAL INSPECTION UNDER THE MICROSCOPE SHOWED EXCESS SOLVENT NEAR THE MALE LUER FOR FIVE SAMPLES AND NEAR THE FEMALE LUER FOR ONE SAMPLE. A QUALITY NOTIFICATION WAS SENT TO THE MANUFACTURER. FROM THE MANUFACTURERS INVESTIGATION, THE USE OF AN INCORRECT PIN IS ACCEPTED AS THE ROOT CAUSE. AS A PREVENTIVE ACTION, THE QUALITY SAMPLING FOR THE OCCLUSION TEST WAS INCREASED, IN A PERIOD FROM APRIL 11 TO JUNE 30, 2023. AS A CORRECTIVE ACTION, THE USE OF PIN 1.4 IN MEDICA 9 WILL BE ENSURED, IN THE ME2020 MODEL, ACCORDING TO PROCEDURE. A DEVICE HISTORY RECORD REVIEW FOR MODEL ME2020 LOT NUMBER 22099223 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL ME2020 LOT NUMBER 22109120 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Additional Manufacturer Narrative · 0

    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. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 22099223. MEDICAL DEVICE EXPIRATION DATE: 13-JUL-2027. DEVICE MANUFACTURE DATE: 09-SEP-2022. MEDICAL DEVICE LOT #: 22109120. MEDICAL DEVICE EXPIRATION DATE: 17-OCT-2027. DEVICE MANUFACTURE DATE: 06-OCT-2022. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7 OF THE BD MAXGUARD EXTENSION SET WERE OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE RECEIVED A TOTAL OF SEVEN EXTENSION TUBING (ME2020) THAT WERE OCCLUDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7 OF THE BD MAXGUARD EXTENSION SET WERE OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE RECEIVED A TOTAL OF SEVEN EXTENSION TUBING (ME2020) THAT WERE OCCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164835 BD MAXGUARD EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEE H.10 10885403236259

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown