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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: I.V. ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR

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I.V. ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Pain (1994)
Event Date 04/11/2020
Event Type  Injury  
Event Description
Pt reports that while being hospitalized for covid-19 at (b)(6), she had two ivs inserted into her right arm. Pt states that she repeatedly asked nurse to remove the iv due to pain but the nurse refused. Pt reports allegedly after discharge that she felt a foreign body inside her right arm from one of the ivs and that the skin surrounding the insertion site was green and purple, akin to a bruise. Pt states returning to the hospital emergency room on (b)(6) 2020 feeling that a piece of metal had broken off from iv and remained inside her arm. Pt states negative ultrasound and xray for foreign body but states persisting pain. Pt alleges that emergency room physician reported possible incidents of retained foreign bodies due to iv breakage. Pt describes that pain is intermittent but during episodes she cannot use her arm because of pain severity. Pt reports last pain incident was about 2-3 weeks ago and notes moving sensation of foreign body in her arm and notes possible nerve injury. Pt states displeasure with the quality of care at this facility and feels that she should not shoulder financial responsibility for adverse events sustained while in hospital care.
 
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Brand NameI.V. ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key11776278
MDR Text Key249221943
Report NumberMW5101144
Device Sequence Number1
Product Code FPA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
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

Patient Treatment Data
Date Received: 05/04/2021 Patient Sequence Number: 1
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