BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FEMALE LUER-LOK ADAPTER

    MDR report key: 16402255 · Received February 20, 2023

    Report

    Report Number
    9616066-2023-00240
    Event Type
    Malfunction
    Date Received
    February 20, 2023
    Date of Event
    February 3, 2023
    Report Date
    March 3, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    70885403484188
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 24-FEB-2023. INVESTIGATION SUMMARY: A COMPLAINT OF CRACKS IN THE COMPONENT WAS RECEIVED FROM THE CUSTOMER. SAMPLES WERE RECEIVED AT NAMC FOR INVESTIGATION. CUSTOMER NOTIFIED THE CRACKS WERE NOT PRESENT POST BONDING PROCESS. THE CRACKS WERE FOUND AFTER THE BONDING PROCESS WITH THE TUBING ON THE NAMC PRODUCT AT THE CUSTOMER SITE. THE BONDING PROCESS UTILIZES THE USE OF BONDING AGENT CYC - CYCLOHEXANONE. THERE HAVE BEEN NO QUALITY NOTIFICATIONS DOCUMENTED FOR PART NUMBER 1022-156-032 RELATED TO THE CRACKS OF THE NATURE AS SHOWN IN THE PROVIDED PHOTO. DURING INVESTIGATION, THE MOISTURE CHECKS WERE REVIEWED. THERE WERE NO FAILURES AND THE RESIN USED DURING THE MOLDING WAS IN THE ACCEPTABLE CONDITION. THE PARTS WERE TESTED USING A CRIMPER ON THE CRACKED PORTION TO IMITATE THE CRACKS. THE PARTS ELONGATED LIKE A THERMOPLASTIC STRETCH. IF THE PARTS WERE BRITTLE, THEY WOULD SHATTER INTO PIECES. THEREFORE, THE PARTS WERE NOT BRITTLE. THE CRACKS PRESENT ON THE PARTS LOOKED LIKE THE CRACKS CREATED BY CYCLOHEXANONE AGENT REACTION. THEREFORE, THIS IS AN EVENT OF FAILURE DURING ASSEMBLY AT THE CUSTOMER BONDING PROCESS STEP, DUE TO THE CYCLOHEXANONE REACTION AND THE CRACKS VISIBLE ON THE SAMPLES PROVIDED BY THE CUSTOMER RESEMBLE THE CRACKS DUE TO THE REACTION WITH BONDING AGENT. ADDITIONALLY, THE PARTS ARE NOT BRITTLE FROM NAMC TEST. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD FEMALE LUER-LOK ADAPTER WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED CRACKS PRESENT AFTER THE ITEMS WENT THROUGH THE BONDING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD FEMALE LUER-LOK ADAPTER WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED CRACKS PRESENT AFTER THE ITEMS WENT THROUGH THE BONDING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677050 BD FEMALE LUER-LOK ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2017556 70885403484188

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown