BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPIT, 14.5 FR, ST, 23CM,MI, W/STIFFWIRE

    MDR report key: 8471715 · Received April 1, 2019

    Report

    Report Number
    3006260740-2019-00750
    Event Type
    Malfunction
    Date Received
    April 1, 2019
    Date of Event
    March 5, 2019
    Report Date
    June 26, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MSD
    UDI-DI
    00801741013287
    PMA / PMN Number
    K030020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS, AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: A SAMPLE EVALUATION COULD NOT BE PERFORMED, AS THE DEVICE WAS NOT RETURNED. HOWEVER, ONE ELECTRONIC PHOTO WAS PROVIDED FOR REVIEW. THE PHOTO SHOWS ONE OF THE TWO GUIDEWIRE DEVICES FOR THE KIT. THE DEVICE APPEARS TO BE INTACT WITH NO ISSUES THE IMAGE OF THIS GUIDEWIRE DOES NOT PROVIDED ANY INFORMATION ABOUT ANY DEFECTS OR ABSENCE OF THE OTHER GUIDEWIRE. BASED ON THE PHOTO REVIEW, THE MISSING J CONNECTOR CANNOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL FACTORS CONTRIBUTED TO THE EVENT. POSSIBLE CONTRIBUTING FACTORS INCLUDE COMPONENT MISPLACED AFTER KIT OPENED AND IMPROPERLY PACKAGED. POTENTIAL ROOT CAUSES LISTED IN THE FMEA ARE IMPROPER TRAINING, PERSONAL FATIGUE, AND IMPROPER MATERIAL HANDLING. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTS (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. (EXPIRATION DATE 05/2019).

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS, AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. IMAGES AND MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED MISSING COMPONENT AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE KIT. THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL FACTORS CONTRIBUTED TO THE EVENT. POSSIBLE CONTRIBUTING FACTORS INCLUDE COMPONENT MISPLACED AFTER KIT OPENED AND IMPROPERLY PACKAGED; HOWEVER, THE LACK OF A RETURNED SAMPLE PREVENTED BOTH CONFIRMATION OF THE REPORTED EVENT AND IDENTIFICATION OF A ROOT CAUSE(S). LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTS (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. (EXPIRATION DATE 05/2019).

    Description of Event or Problem · 0

    IT WAS ORIGINALLY REPORTED THAT DURING PREPARATION THE J CONNECTOR OF THE GUIDE WIRE WAS ALLEGEDLY ABSENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS ORIGINALLY REPORTED THAT DURING PREPARATION THE J CONNECTOR OF THE GUIDE WIRE WAS ALLEGEDLY ABSENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT CONTACT.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE RETURN OF THE DEVICE IS PENDING. THE INVESTIGATION IS CURRENTLY UNDER WAY. (EXPIRATION DATE 05/2019).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT DURING PREPARATION THE J CONNECTOR OF THE GUIDE WIRE WAS ALLEGEDLY ABSENT. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265067 HEMOSPIT, 14.5 FR, ST, 23CM,MI, W/STIFFWIRE DIALYSIS CATHETER MSD BARD ACCESS SYSTEMS 5743730 REBT1835 00801741013287

    Patients

    Seq Age Sex Outcome Treatment
    1