BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT SET DEHP FREE

    MDR report key: 10604061 · Received September 29, 2020

    Report

    Report Number
    9616066-2020-02811
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    August 19, 2020
    Report Date
    September 9, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FPA
    UDI-DI
    10885403234668
    PMA / PMN Number
    K790108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT HUB CRACKED ON MED LINE. RECEIVED FROM THE CUSTOMER WAS A USED EXTENSION SET MODEL 11088483 LOT UNKNOWN. THE AS-RECEIVED SET SAMPLE WAS INSPECTED FOR KINKS, HOLES/TEARS IN THE TUBING, OR DAMAGES TO THE COMPONENTS. THERE WAS A CRACK ALONG THE SIDE OF THE SET'S FEMALE LUER LOCK P/N 630-01364 COMPONENT (CAVITY 21). A PIECE OF THE TOP FEMALE LUER WAS BROKEN OFF. THE CRACK WAS OBSERVED TO BE APPROXIMATELY OPPOSITE THE INJECTION GATE ON THE LUER COMPONENT. THE LOCATION OF THE INJECTION GATE (BELOW THE WINGS/TABS) INDICATES THAT THIS FEMALE LUER WAS MANUFACTURED AFTER THE CHANGE ORDER (CO # 1109132) THAT MOVED THE INJECTION GATE TO A LOWER LOCATION TO HELP MITIGATE AND PREVENT FEMALE LUER CRACKS. NO TOOL MARKINGS WERE OBSERVED AROUND THE OBSERVED DAMAGED AREA. NO OTHER DAMAGE OR ISSUE WAS OBSERVED. ALTHOUGH DAMAGE WAS OBSERVED, FUNCTIONAL TESTING WAS PERFORMED. FLUID FROM A 10LAB SYRINGE WAS PUSHED THROUGH. THE FLUID LEAKED FROM THE CRACK. NO OTHER LEAK WAS OBSERVED. EQUIPMENT USED (INSPECTION PERFORMED ON 5-OCT2020): - RAM OPTICAL INSTRUMENTATION/EQ08204/CALIBRATION DUE DATE 5-FEB-2021. DEVICE HISTORY RECORD COULD NOT BE PERFORMED ON MODEL 11088483 BECAUSE THE LOT # FOR THE SUSPECT SET WAS NOT PROVIDED. THE CUSTOMER'S REPORT THAT THE HUB CRACK WAS CONFIRMED UPON VISUAL INSPECTION. THE ROOT CAUSE OF THE FEMALE LUER CRACK WAS IDENTIFIED TO BE A RESULT OF INTERNAL STRESSES CREATED DURING THE MANUFACTURING PROCESS THAT MAKE IT MORE SUSCEPTIBLE TO CHEMICAL/MECHANICAL ATTACKS AND THE PVC MATERIALS USED IN THE NEW FEMALE LUER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EXT SET DEHP FREE HUB CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 11088483 BATCH NO: UNKNOWN. IT WAS REPORTED THAT HUB CRACKED ON MED LINE. CUSTOMER RESPONSE 16-SEP-2020: (B)(6) (MM REPORT #(B)(6)): - WAS THERE ANY ADVERSE EVENT(S) AS A RESULT OF THE REPORTED DEFECT? NONE REPORTED. O IF YES, PLEASE PROVIDE DETAILS, IN ADDITION TO PATIENT IDENTIFIERS (INITIALS, SEX, DOB, DIAGNOSIS, ETC.) AND DATE. N/A.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXT SET DEHP FREE HUB CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 11088483 BATCH NO: UNKNOWN. IT WAS REPORTED THAT HUB CRACKED ON MED LINE. CUSTOMER RESPONSE 16-SEP-2020: (B)(6) ((B)(4)): WAS THERE ANY ADVERSE EVENT(S) AS A RESULT OF THE REPORTED DEFECT? NONE REPORTED. O IF YES, PLEASE PROVIDE DETAILS, IN ADDITION TO PATIENT IDENTIFIERS (INITIALS, SEX, DOB, DIAGNOSIS, ETC.) AND DATE. N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068326 EXT SET DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA CAREFUSION SD 11088483 UNKNOWN 10885403234668

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200819.| 20200819.