BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXGUARD¿ EXTENSION SET

    MDR report key: 17044011 · Received June 1, 2023

    Report

    Report Number
    9616066-2023-01060
    Event Type
    Malfunction
    Date Received
    June 1, 2023
    Date of Event
    May 9, 2023
    Report Date
    August 30, 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
    KS, 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: 26-JUN-2023. INVESTIGATION SUMMARY: THREE SAMPLES OF MODEL ME2020 WERE RECEIVED FOR QUALITY INVESTIGATION. TWO SAMPLES RECEIVED DID NOT COME IN ITS ORIGINAL PACKAGING AND THEIR LOT NUMBERS ARE UNKNOWN. ONE SAMPLE ADDITIONAL SAMPLE WAS RECEIVED UNOPENED AND WITH LOT # 22109117. THE CUSTOMER COMPLAINT OF FOREIGN MATTER WAS CONFIRMED BY INSPECTION AND TESTING OF THE TWO USED SAMPLES. THE TWO SAMPLES THAT DID NOT COME WITH KNOWN LOT NUMBERS WERE FIRST VISUALLY INSPECTED FOR FOREIGN MATTER. AT THE UNION BETWEEN THE TUBING AND THE MALE LUER CONNECTOR, THERE LOOKED TO BE AN EXCESSIVE AMOUNT OF SOLVENT. GIVING THE APPEARANCE OF PLASTIC INSIDE THE FLUID LINE. AN ADDITIONAL TEST WAS CONDUCTED TO TEST IF THE EXTENSION SETS WERE OCCLUDED DUE TO THE AMOUNT OF BLOCKAGE SEEN IN THE FLUID PATH. WATER WAS USED WITH A 10ML SYRINGE IN ORDER TO PUSH THE FLUID THROUGH THE TUBING. BOTH SETS OF THE UNKNOWN LOT NUMBERS DID NOT ALLOW FLOW THROUGH THE TUBING. THE SAMPLE THAT WAS UNUSED AND STILL IN THE PACKAGING WAS ALSO INSPECTED, AND IT DID NOT SHOW THE SAME FOREIGN MATTER AT ANY OF ITS COMPONENT UNION LOCATIONS. THE UNOPENED SET WAS ALSO TESTED FOR FLOW, AND DID NOT SHOW SIGNS OF FLUID BLOCKAGE OR OCCLUSION. A DEVICE HISTORY RECORD REVIEW FOR MODEL ME2020 LOT NUMBER 22129151 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THE ISSUE SEEN IN THIS COMPLAINT IS EXCESS OF SOLVENT HAVING BEEN APPLIED AT THE UNION BETWEEN THE TUBING OF THE EXTENSION SET AND THE MALE LUER ADAPTER. AN INVESTIGATION AT THE MANUFACTURING FACILITY IDENTIFIED THE ROOT CAUSE OF THE OCCLUSION COULD BE RELATED TO THE INCORRECT APPLICATION OF SOLVENT IN THE TUBING AND THE ISSUE NOT BEING IDENTIFIED DUE TO THE ASSEMBLER NOT USING THE OCCLUSION TEST EQUIPMENT. A QUALITY NOTIFICATION HAS BEEN ISSUED TO COMMUNICATE AND REINFORCE THE USE OF THE OCCLUSION TEST FIXTURE DURING THE ASSEMBLY PROCESS.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 23019157; D.4. MEDICAL DEVICE EXPIRATION DATE:,14-JAN-2028, H.4. DEVICE MANUFACTURE DATE: 10-JAN-2023; D.4. MEDICAL DEVICE LOT #: 22109117, D.4. MEDICAL DEVICE EXPIRATION DATE: 06-OCT-2027, H.4. DEVICE MANUFACTURE DATE: 06-OCT-2022; D.4. MEDICAL DEVICE LOT #: 22129167, D.4. MEDICAL DEVICE EXPIRATION DATE: 13-DEC-2027, H.4. DEVICE MANUFACTURE DATE: 07-DEC-2022; D.4. MEDICAL DEVICE LOT #: 22129151, D.4. MEDICAL DEVICE EXPIRATION DATE: 10-DEC-2027, H.4. DEVICE MANUFACTURE DATE: 07-DEC-2022. H.3. 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 ONE BD MAXGUARD¿ EXTENSION SET EACH FROM LOTS 23019157, 22109117, 22129167, AND 22129151 HAD ISSUES WITH FOREIGN PLASTIC OCCLUDING THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INQUIRER STATES EXTENSION SET, ME2020, WAS GIVEN TO A CUSTOMER AND THE NURSE NOTICED THE TUBING LINE WAS OCCLUDED WITH PLASTIC. THERE WERE A FEW SETS THIS WAY, BUT THEY WERE NOT USED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE BD MAXGUARD¿ EXTENSION SET EACH FROM LOTS 23019157, 22109117, 22129167, AND 22129151 HAD ISSUES WITH FOREIGN PLASTIC OCCLUDING THE TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INQUIRER STATES EXTENSION SET, ME2020, WAS GIVEN TO A CUSTOMER AND THE NURSE NOTICED THE TUBING LINE WAS OCCLUDED WITH PLASTIC. THERE WERE A FEW SETS THIS WAY, BUT THEY WERE NOT USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186003 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