BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 7144115 · Received December 22, 2017

    Report

    Report Number
    3006948883-2017-00188
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    December 2, 2017
    Report Date
    January 26, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    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 · 1

    RESULTS: BD RECEIVED ONE SAMPLE FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE FAILURE MODE WAS OBSERVED IN THE SAMPLE PROVIDED BY THE CUSTOMER, AND NO ADDITIONAL ABNORMALITIES IN THE INCOMING MATERIAL, ASSEMBLY PROCESS OR PACKAGING PROCESS WERE OBSERVED IN THE BATCH RECORD. THE INDWELLING NEEDLE WAS BEING USED FOR 4 DAYS (B)(6) IT WAS FINE FOR THE FIRST 3 AND FAILED ON THE FOURTH. BECAUSE THE UNIT BEHAVED NORMALLY FOR THE FIRST THREE DAYS IT WAS DETERMINED TO BE WITHIN SPECIFICATION. (B)(4) CANNOT FINALIZE THE ROOT CAUSE OF THE PLANT AS A RESULT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER. CONCLUSION: IN CONCLUSION, BASED ON THE CURRENT INVESTIGATION, NO ABNORMALITY WAS FOUND AT THE BEGINNING OF USING. (B)(4) PLANT CAN'T FINALIZE THE ROOT CAUSE FOR THIS KIND OF FAILURE.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: 7083015, MEDICAL DEVICE EXPIRATION DATE: 3/31/2020, DEVICE MANUFACTURE DATE: 3/24/2017. MEDICAL DEVICE LOT #: 7110497, MEDICAL DEVICE EXPIRATION DATE: 4/30/2020, DEVICE MANUFACTURE DATE: 4/20/2017. 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 ON DAY TWO OF USING THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM IT MALFUNCTIONED AS THE CATHETER WAS FOUND WITH THE ¿INDWELLING PORTION MISSING FROM THE ROOT OF THE TUBE.¿ MEDICAL INTERVENTION WAS NEEDED AND AN X- RAY WAS PERFORMED. IT IS UNKNOWN WHAT FURTHER MEDICAL INTERVENTION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923730 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other