BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PEGASUS 20 G X 1.16 IN

    MDR report key: 5297796 · Received December 15, 2015

    Report

    Report Number
    3006948883-2015-00008
    Event Type
    Injury
    Date Received
    December 15, 2015
    Date of Event
    October 28, 2015
    Report Date
    December 18, 2015
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM - THE PATIENT WAS HAVING A CARDIAC MRI AT TIME OF EVENT. THE PATIENT'S HOSPITALIZATION WAS IN THE CARDIOLOGY DEPARTMENT. DEVICE EVALUATION: RESULT - A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 4294424. ONE UNUSED SAMPLE OF A BD PEGASUS 20G WAS RECEIVED (B)(6) 2015 FROM LOT NUMBER 5041010, WHICH IS NOT THE REPORTED LOT NUMBER FOR THIS INCIDENT. A VISUAL INSPECTION BY MICROSCOPE WAS PERFORMED. NO ABNORMALITY IS FOUND IN THE IN-COMING/ASSEMBLY PROCESS AND MACHINE MAINTENANCE RECORD. NO ABNORMALITY IS FOUND IN THE IN-PROCESS INSPECTION. NO ABNORMALITY IS FOUND ON THE RETURNED SAMPLE. THE TORQUE WAS DETERMINED BY QA INSPECTION AND WAS FOUND WITHIN THE SCOPE OF PRODUCT REQUIREMENTS. WHEN THE END CAP IS SCREWED ON, NO LEAKAGE IS FOUND UNDER 6 PSI AND 45 PSI INSPECTION AND NO END CAP LOOSENING APPEARED. BECAUSE THE MATERIAL OF END CAP AND EXTENSION TUBING ADAPTER ARE DIFFERENT, THE SHRINKAGE OF THE TWO MATERIALS IN TEMPERATURE CHANGES IS DIFFERENT. TEMPERATURE CHANGE AND VIBRATION DURING TRANSPORTATION MAY LEAD TO LOWER TORQUE. THEREFORE, INSPECTION OF THE CONNECTION OF THE END CAP BEFORE PUNCTURE IS A REQUIREMENT PER THE PRODUCT INSTRUCTIONS. CONCLUSION - THIS INCIDENT MAY BE CAUSED BY TEMPERATURE CHANGE AND VIBRATION DURING TRANSPORTATION WHICH LEADS TO LOWERING THE TORQUE OF THE END CAP. THE END CAP CONNECTION SHOULD BE TESTED PRIOR TO USE. THE INSPECTION OF THE RETURNED SAMPLE MEETS ALL STANDARD REQUIREMENTS. HOWEVER, THE CUSTOMER'S COMPLAINT CANNOT BE CONFIRMED AS THE RETURNED SAMPLE IS NOT FROM THE SAME LOT AS THE SUSPECT DEVICE USED IN THIS INCIDENT. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. SEE DEVICE EVALUATION IN MANUFACTURER NARRATIVE.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN MRI, THE PATIENT WAS RECEIVING AN INFUSION AT 3 ML/SECOND THROUGH THE DEVICE WHEN THE END CAP CAME LOOSE AND BLOOD LEAKED. THE PATIENT LOST ABOUT 40 ML OF BLOOD DUE TO THE LEAKAGE. BLOOD TESTS WERE PERFORMED AND REVEALED A NORMAL HEMOGLOBIN. THE PATIENT STAYED IN THE HOSPITAL FOR ABOUT 2 WEEKS BECAUSE HE/SHE WAS "VERY UNSATISFIED WITH THE INCIDENT". THE PATIENT WAS LATER DIAGNOSED BY THE NEUROLOGIST WITH ANXIETY AND DEPRESSION DUE TO THE BLOOD LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828010 BD PEGASUS 20 G X 1.16 IN INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 4294424

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention