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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MRI MACHINE SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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MRI MACHINE SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Device Problems Improper or Incorrect Procedure or Method (2017); Device Unsafe to Use in Environment (2918)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2018
Event Type  No Answer Provided  
Event Description
In 2018, at the university of xxxxx medical center, an rn took an unopened fresenius kabi simplist hydromorphone 1mg/ml pre-filled syringe into the mri room. This syringe was then sucked into the mri. No one was harmed from this incident. Spoke with fresenius kabi pharmaceutical customer service clinical / technical questions line. The blister pack is made using aluminum packaging and the oxygen canister has a potential for metal, specifically iron, however the oxygen canister has not been tested. The syringe is composed of glass barrel with plastic luer lock adapter, plastic rigid tip cap and elastomeric tip cap. Again, no mri testing has been done to confirm whether the syringe is fully compatible. Exact product that was sucked into the machine is not available but may have been the following: name: hydromorphone 1mg/ml, ndc: (b)(4), lot: 6400239. Medication administered to or used by the patient: yes; outcome: no one was harmed from this incident. Where did the error occur: hospital; (b)(6).
 
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Brand NameMRI MACHINE
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
MDR Report Key8228371
MDR Text Key132632630
Report NumberMW5082938
Device Sequence Number2
Product Code LNH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 01/07/2018
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received01/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
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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