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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIDLINE CATHETER

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MIDLINE CATHETER Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2021
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical iv catheter was being removed by nurse, catheter broke off in patients arm requiring removal by vascular surgeon. There were no other reported adverse events.
 
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Type of DeviceMIDLINE CATHETER
MDR Report Key12202672
MDR Text Key264938469
Report Number3012307300-2021-07439
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 07/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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