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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL SET, ADMINISTRATION, INTRAVASCULAR

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NULL SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Fluid Leak (1250)
Patient Problem Dyspnea (1816)
Event Date 11/12/2020
Event Type  malfunction  
Manufacturer Narrative
No product was returned but leak testing was reviewed in the manufacturing. No issues was found during review of current manufacturing processes. No root cause could determine since the complaint could not be confirmed since no samples or pictures were received for evaluation. No corrective actions are required since the complaint could not be confirmed since no samples or pictures were received for evaluation.
 
Event Description
Information was received indicating that a smiths medical product was found to be leaking from the little hole in the filter on the tubing. The leak was noticed when the patient found a wet spot on their poop and was unable to breath well. The tubing was changed at this time and the issue was resolved. The patient said that the this was not the first time this happened. This issue occurs approximately every other tubing according to the patient. The patient was using remodulin mdv, 10mg/ml, dose of 154 ng/kg/min, continuous intravenous. There were no reported adverse events.
 
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Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section G)
NULL
MDR Report Key11004149
MDR Text Key221453345
Report Number3012307300-2020-12348
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/17/2020
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 Initial

Patient Treatment Data
Date Received: 12/14/2020 Patient Sequence Number: 1
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