BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXGUARD¿ EXTENSION SET

    MDR report key: 16607602 · Received March 23, 2023

    Report

    Report Number
    9616066-2023-00551
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    March 8, 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: 30-MAR-2023. H6: INVESTIGATION SUMMARY: FOUR SAMPLES MODEL: ME2020, LOT: 22099223 WERE RETURNED FOR INVESTIGATION. THE SETS WERE EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SETS WERE ATTACHED TO A 10ML BD SYRINGE FILLED WITH WATER. FOUR SAMPLES WERE UNABLE TO BE FLUSHED. VISUAL INSPECTION UNDER A MICROSCOPE SHOWED SIGNS OF EXCESS SOLVENT NEAR THE MALE LUER BOND. A QUALITY NOTIFICATION WAS SENT TO THE MANUFACTURER. ONE SAMPLE MODEL: ME2020, LOT: 22119006 WERE RETURNED FOR INVESTIGATION. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SET WAS ATTACHED TO A 10ML BD SYRINGE FILLED WITH WATER. THE SAMPLE WAS UNABLE TO BE FLUSHED. VISUAL INSPECTION UNDER A MICROSCOPE SHOWED SIGNS OF EXCESS SOLVENT NEAR THE MALE LUER BOND. 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: 22099085, 22099223, AND 22119006 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. ONE SAMPLE MODEL: ME2020, LOT: 22099085 WERE RETURNED FOR INVESTIGATION. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SET WAS ATTACHED TO A 10ML BD SYRINGE FILLED WITH WATER. THE SAMPLE WAS ABLE TO BE FLUSHED. THE CUSTOMER COMPLAINT THAT THE SET WAS UNABLE TO BE FLUSHED COULD NOT BE REPLICATED. THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE ISSUE COULD NOT BE REPLICATED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 22099223; MEDICAL DEVICE EXPIRATION DATE: 13-SEP-2027; DEVICE MANUFACTURE DATE: 09-SEP-2022. MEDICAL DEVICE LOT #: 22119006; MEDICAL DEVICE EXPIRATION DATE: 03-NOV-2027; DEVICE MANUFACTURE DATE: 01-NOV-2022. MEDICAL DEVICE LOT #: 22099085; MEDICAL DEVICE EXPIRATION DATE: 05-SEP-2027; DEVICE MANUFACTURE DATE: 04-SEP-2022. MEDICAL DEVICE LOT #: UNKNOWN; MEDICAL DEVICE EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD MAXGUARD¿ EXTENSION SETS EACH FROM LOTS: 22099223 AND AN UNSPECIFIED LOT, AS WELL AS 1 SET EACH FROM LOTS: 22119006 AND 22099085 HAD OCCLUSION ISSUES WITH THEIR TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I DO HAVE TEN NEW TUBINGS IN MY POSSESSION TO SEND AS WELL, ALL WITH OCCLUSION ISSUES. ALL OF THESE HAVE HAPPENED FROM FEB 28TH ¿ MARCH 6TH. I CAN'T GIVE EXACT DATES ON EACH ONE. ALL OF THESE HAVE BEEN WHILE PRIMING THE TUBING BEFORE EVER MAKING IT TO THE PATIENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD MAXGUARD¿ EXTENSION SETS EACH FROM LOTS 22099223 AND AN UNSPECIFIED LOT, AS WELL AS 1 SET EACH FROM LOTS 22119006 AND 22099085 HAD OCCLUSION ISSUES WITH THEIR TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I DO HAVE TEN NEW TUBINGS IN MY POSSESSION TO SEND AS WELL, ALL WITH OCCLUSION ISSUES. ALL OF THESE HAVE HAPPENED FROM FEB 28TH ¿ MARCH 6TH. I CAN¿T GIVE EXACT DATES ON EACH ONE... ALL OF THESE HAVE BEEN WHILE PRIMING THE TUBING BEFORE EVER MAKING IT TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472155 BD MAXGUARD¿ EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEE H10 10885403236259

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown