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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IV EXTN SET 12" MICROBORE SET, ADMINISTRATION, INTRAVASCULAR

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IV EXTN SET 12" MICROBORE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MS438
Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Patient Problem Dizziness (2194)
Event Type  Injury  
Event Description
Patient reports she sometimes allows the pump to go past 48 hours and changes cassette when it alarms. She also reports last month the tubing came undone for a bit and she was not infusing. She reports feelings slightly light headed. She was able to reconnect and begin infusing again. Did the reported product fault occur while in use with the patient? yes; did the product issue cause or contributed to patient or clinical injury? no; is the actual device available for investigation? no; did we [mfr] replace device? no; did the patient have a backup device they were able to switch to? non/applicable; if yes, was the patient able to successfully continue their infusion? non/applicable; if no, what was the patient instructed to do in able to continue their infusion? non/applicable; the infusion life sustaining? yes; what is the outcome of the event? resolved? ongoing? resolved. Reported to (b)(6) by pt/caregiver.
 
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Brand NameIV EXTN SET 12" MICROBORE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key10762865
MDR Text Key214130633
Report NumberMW5097572
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMS438
Device Catalogue NumberMS438
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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