BEUDAMED
    FDA Adverse Event Other Summary report: N

    PER Q CATH PLUS

    MDR report key: 296185 · Received September 14, 2000

    Report

    Report Number
    296185
    Event Type
    Other
    Date Received
    September 14, 2000
    Date of Event
    September 2, 2000
    Report Date
    September 13, 2000
    Manufacturer
    BARD ACCESS SYSTEM
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PICC LINE OCCLUDED WHILE INFUSING RIFAMPIN DOSE. 32ML OF 55ML INFUSED WHEN LINE OCCLUDED. UNABLE TO CLEAR. LINE DISCONTINUED. NEW PICC PLACED. TWO DAYS LATER WHILE INFUSING RIFAMPIN OF SAME LOT#, NEW LINE OCCLUDED AGAIN. REQUIRED LINE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PER Q CATH PLUS PICC-SINGLE LUMEN 3 FR DQO BARD ACCESS SYSTEM 4133100 511TJ2753

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other 1. RIFAMPIN 600MG IV BEDFORD LAB, LOT #196197,| 9/2/00 EXPDATE 1/02.| 9/4/2000 EXPDATE 1/02.| 2. RIFAMPIN 600MG IV BEDFORD LAB, LOT 196197