BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPLIT 14.5 FR,ST,19CM,MI, W/STIFFWIRE

    MDR report key: 10012061 · Received April 29, 2020

    Report

    Report Number
    3006260740-2020-01566
    Event Type
    Malfunction
    Date Received
    April 29, 2020
    Date of Event
    April 9, 2020
    Report Date
    October 19, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MSD
    UDI-DI
    00801741013263
    PMA / PMN Number
    K030020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER AND THIS LOT MEETS ALL RELEASE CRITERIA. THE MANUFACTURING REVIEW DID NOT INDICATE ANY POSSIBLE MANUFACTURING ISSUE THAT COULD BE RELATED TO THE REPORTED EVENT. INVESTIGATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION. ONE ELECTRONIC PHOTO WAS PROVIDED FOR REVIEW. THE INVESTIGATION IS CONFIRMED FOR UNSEALED MICRO INTRODUCER KIT AS PHOTO SHOWS UNSEALED PACKING OF THE MICRO INTRODUCER KIT. BUT, NO SEAL TRANSFER IS SEEN IN THE INNER EDGES OF THE PACKAGE. THE PACKAGING ENGINEERING REVIEW NOTED THAT THE POUCH MAY NOT HAVE BEEN SEALED PROPERLY. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H10: D4 (EXPIRATION DATE: 04/2021), G4 H11: H6(RESULTS AND CONCLUSION) H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO DIALYSIS CATHETER PLACEMENT, THE DEVICE ALLEGEDLY FOUND NOT SEALED UPON OPENING THE OUTER PACKAGE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER DIALYSIS CATHETER. THERE WAS NO PATIENT CONTACT.

    Additional Manufacturer Narrative · 1

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, HOWEVER PHOTOS HAVE BEEN PROVIDED. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRATION DATE: 04/2021).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO DIALYSIS CATHETER PLACEMENT, THE MICRO-INTRODUCER KITS WERE NOT SEALED. AFTER THE OUTER PACKAGE OF THIS PRODUCT WAS OPENED, IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER DIALYSIS CATHETER. THERE WAS NO REPORTED PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475263 HEMOSPLIT 14.5 FR,ST,19CM,MI, W/STIFFWIRE DIALYSIS CATHETER MSD BARD ACCESS SYSTEMS 5743690 REDT4000 00801741013263

    Patients

    Seq Age Sex Outcome Treatment
    1