BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEGASUS YEL 24GA X 0.75IN PRN

    MDR report key: 8454055 · Received March 26, 2019

    Report

    Report Number
    3006948883-2019-00215
    Event Type
    Injury
    Date Received
    March 26, 2019
    Date of Event
    March 7, 2019
    Report Date
    April 16, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    LJS
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233182. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, DURING THE VISUAL EVALUATION OF THE RETURNED DEVICE, BD ENGINEERS IDENTIFIED CHARACTERISTICS, IN THE BROKEN EDGE OF THE EXTENSION TUBING, THAT ARE CHARACTERISTIC OF CLAMP DAMAGE. THE CORRESPONDING SLIDE CLAMP WAS MISSING PREVENTING OUR INVESTIGATORS FROM EVALUATING THE SURFACE OF THE COMPONENT FOR BURRS OR OTHER NON-CONFORMANCE'S. UNFORTUNATELY WITHOUT THIS COMPONENT, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEGASUS YEL 24GA X 0.75IN PRN EXPERIENCED SEPARATION DURING USE AND CAUSED A SERIOUS INJURY IN THE FORM OF A PORTION OF THE CATHETER POTENTIALLY BEING EMBEDDED WITHIN PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: THE PATIENT LEFT THE HOSPITAL WITH THE CATHETER PLACED. IT'S FOUND THAT THE CATHETER/CATHETER HUB AND CLAMP WERE MISSING WHILE THE TAPE REMAINED ON THE SKIN. THE NURSE FOUND PARTIAL EXTENSION TUBING AND LUER CONNECTOR LEFT. THE PATIENT WAS DOUBTING THE CATHETER ENTERED IN THE BODY. THE HOSPITAL ARRANGED COLOR ULTRASOUND EXAMINATION AND CT, DIDN'T FIND THE CATHETER RESIDUE. BASED ON THE COMMUNICATION, HIGHLY SUSPICIOUS THAT THE CATHETER EXTENSION TUBING WAS DAMAGED WHEN THE PATIENT TOOK OFF THE CLOTHES AT HOME THE NIGHT HE/SHE LEFT THE HOSPITAL.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEGASUS YEL 24GA X 0.75IN PRN EXPERIENCED SEPARATION DURING USE AND CAUSED A SERIOUS INJURY IN THE FORM OF A PORTION OF THE CATHETER POTENTIALLY BEING EMBEDDED WITHIN PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: THE PATIENT LEFT THE HOSPITAL WITH THE CATHETER PLACED. IT'S FOUND THAT THE CATHETER/CATHETER HUB AND CLAMP WERE MISSING WHILE THE TAPE REMAINED ON THE SKIN. THE NURSE FOUND PARTIAL EXTENSION TUBING AND LUER CONNECTOR LEFT. THE PATIENT WAS DOUBTING THE CATHETER ENTERED IN THE BODY. THE HOSPITAL ARRANGED COLOR ULTRASOUND EXAMINATION AND CT, DIDN'T FIND THE CATHETER RESIDUE. BASED ON THE COMMUNICATION, HIGHLY SUSPICIOUS THAT THE CATHETER EXTENSION TUBING WAS DAMAGED WHEN THE PATIENT TOOK OFF THE CLOTHES AT HOME THE NIGHT HE/SHE LEFT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247196 PEGASUS YEL 24GA X 0.75IN PRN CATHETER LJS BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 8233182

    Patients

    Seq Age Sex Outcome Treatment
    0 Other