BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAMSHIDI (TJ) NEEDLE BM 8G X 4 ASP MAC

    MDR report key: 7673166 · Received July 10, 2018

    Report

    Report Number
    1625685-2018-00024
    Event Type
    Malfunction
    Date Received
    July 10, 2018
    Date of Event
    May 1, 2018
    Report Date
    August 10, 2018
    Manufacturer
    CAREFUSION, INC
    Product Code
    KNW
    PMA / PMN Number
    K171531
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP EMDR FOR DEVICE EVALUATION. A SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PACKAGE CONFIRMED THE REPORTED FAILURE MODE. THE INSPECTION ALSO NOTED THE PRESENCE OF A SEALING LINE ON THE APPLICABLE POUCH SUGGESTING THE POUCH WAS SEALED PRIOR TO DISPOSITION FROM THE MANUFACTURING FACILITY AND DURING THE DISTRIBUTION PROCESS THE SEAL BECAME OPEN. THE INVESTIGATION WAS NOT ABLE TO IDENTIFY ANY CONTRIBUTION FROM THE FACTORS ABOVE IN REGARDS TO THE OBSERVED FAILURE MODE. A DEVICE HISTORY RECORD REVIEW OF ALL APPLICABLE MANUFACTURING RECORDS FOR LOT 0001159475 DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. A REVIEW OF SEALING PULL STRENGTH MONITORING DATA AND SEALING PARAMETERS DID NOT IDENTIFY ANY ISSUES THAT WOULD HAVE SUGGESTED AN ONGOING ISSUE WITH THE SEALING OPERATION. LIKEWISE, AS PART OF THE MANUFACTURING AND QUALITY INSPECTION PROCESSES, 100% OF ALL THE SEALS OF EVERY POUCH ARE VISUALLY VERIFIED TO ENSURE THE PRESENCE OF A SEALED POUCH. THE INVESTIGATION NOTED THE POTENTIAL FOR THE POUCH SEAL TO OPEN DUE TO ABNORMAL DISTRIBUTION CONDITIONS HOWEVER THE INVESTIGATION WAS NOT ABLE TO CONFIRM ANY ABNORMAL SHIPPING CONDITIONS FOR THIS PRODUCT. SINCE NO PROBABLE ROOT CAUSE WAS IDENTIFIED, THE INVESTIGATION WAS NOT ABLE TO IDENTIFY ANY CORRECTIVE ACTIONS FOR THIS COMPLAINT. AS A PREVENTIVE MEASURE, ALL APPLICABLE ASSOCIATES WILL BE NOTIFIED OF THIS COMPLAINT AND WILL RECEIVE REMEDIAL TRAINING REGARDING THE PROPER MANUFACTURING PROCESSES FOR THE APPLICABLE SEALING OPERATION FOR THIS AFFECTED PRODUCT CODE IN THIS COMPLAINT. THE COMPLAINT WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE THROUGH THE QUALITY DATA ANALYSIS PROCESS.

    Description of Event or Problem · 0

    FOLLOW UP FOR MANUFACTURING INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE POUCH WAS NOT PROPERLY SEALED. THE SEAL WAS PARTIALLY OPEN AND THEREFORE NOT STERILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515296 JAMSHIDI (TJ) NEEDLE BM 8G X 4 ASP MAC NEEDLE, CATHETER KNW CAREFUSION, INC 1159474

    Patients

    Seq Age Sex Outcome Treatment
    1 Other