BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD POWERMIDLINE CATHETER 3F, SINGLE-LUMEN

    MDR report key: 12577185 · Received October 5, 2021

    Report

    Report Number
    3006260740-2021-04130
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 15, 2021
    Report Date
    September 27, 2021
    Product Code
    PND
    UDI-DI
    00801741162763
    PMA / PMN Number
    K153393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REFR0288 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTH PROFESSIONAL CUT HIMSELF ON ONE OF THE PURPLE SCALPELS FROM HIS CUSTOM KIT CK000860. THIS CAUSED A MINOR CUT. HE MENTIONED THAT THE SCALPEL WAS EXTREMELY DIFFICULT TO SAFETY AND UNSAFETY CAUSING HIS FINGER TO DRAG OVER THE BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476653 BARD POWERMIDLINE CATHETER 3F, SINGLE-LUMEN MIDLINE CATHETER PND N/A REFR0288 00801741162763

    Patients

    Seq Age Sex Outcome Treatment
    1 Other