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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 Priming Problem (4040)
Patient Problem Contact Dermatitis (4546)
Event Date 02/01/2022
Event Type  Injury  
Manufacturer Narrative
Device evaluation: no product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.
 
Event Description
It was reported the patient was hospitalized for 5 days for contact dermatitis around her central line.The central line was replaced and the patient was doing much better.Patient had issues with two cassettes in the last week, not priming on both pumps.
 
Manufacturer Narrative
Other text: product information was updated.
 
Manufacturer Narrative
Corrected data: product information was corrected.
 
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Brand Name
SET, ADMINISTRATION, INTRAVASCULAR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section G)
NULL
MDR Report Key13967836
MDR Text Key292735199
Report Number3012307300-2022-05657
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 Other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 06/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/14/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age49 YR
Patient SexFemale
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