BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS CLR POSITIVE DISPLACEMENT CONN

    MDR report key: 11823142 · Received May 13, 2021

    Report

    Report Number
    9616066-2021-50993
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 12, 2021
    Report Date
    May 20, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/26/2021. H.6. INVESTIGATION: SIXTEEN (B)(6) SAMPLES WERE RECEIVED FOR INVESTIGATION; ONE IN SEALED PACKAGING FROM LOT 20065649, NINE IN SEALED PACKAGING FROM LOT 20065650 AND SIX SAMPLES WERE RECEIVED WITHOUT PACKAGING WITH DRIED RESIDUAL FLUID PRESENT. IN ADDITION FOUR 394600 BD CONNECTA SAMPLES WERE RECEIVED TO ASSIST THE INVESTIGATION; THREE FROM LOT 0093330A AND ONE FROM LOT 0093330B. A VISUAL INSPECTION OF THE RETURNED (B)(6) SAMPLES IDENTIFIED A CRACK ON THE FEMALE LUER OF FIVE OF THE MAXPLUS SAMPLES RECEIVED WITHOUT PACKAGING CONFIRMING THE CUSTOMER'S EXPERIENCE, LEAKAGE WAS NOTED FROM THE CRACKS. NO DAMAGE OR LEAKAGE WAS OBSERVED ON THE REMAINING ELEVEN SAMPLES. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20065649 AND 20065650 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. PLEASE NOTE, THE TYPE OF CRACK OBSERVED CAN BE CAUSED OR CONTRIBUTED TO BY A COMBINATION OF DIFFERENT FACTORS, INCLUDING OVER-TORQUE OF THE COMPONENT DURING CONNECTION WITH THE MALE LUER, USE OF A MALE LUER THAT IS NOT COMPLIANT TO ISO STANDARDS, OR PROLONGED USE OF SUBSTANCES THAT ARE AGGRESSIVE TO PLASTICS. FROM THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO SPECULATE WHICH OF THESE FACTORS WERE KEY CONTRIBUTORS TO THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MAXPLUS CLR POSITIVE DISPLACEMENT CONN WAS CRACKED AND LEAKED. THIS OCCURRED ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER EMAILED AND CALLED TO ADVISE THAT THEY HAVE HAD 5 INCIDENCES OF LEAKING CONNECTORS. APPEARS CRACKS IN OUTER CASING? MORE INFORMATION TO COME FORWARDS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MAXPLUS CLR POSITIVE DISPLACEMENT CONN WAS CRACKED AND LEAKED. THIS OCCURRED ON 5 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER EMAILED AND CALLED TO ADVISE THAT THEY HAVE HAD 5 INCIDENCES OF LEAKING CONNECTORS. APPEARS CRACKS IN OUTER CASING? MORE INFORMATION TO COME FORWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712417 MAXPLUS CLR POSITIVE DISPLACEMENT CONN INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20065650

    Patients

    Seq Age Sex Outcome Treatment
    1