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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
Lot Number 3296571
Device Problem Insufficient Information (3190)
Patient Problem Injection Site Reaction (4562)
Event Date 03/10/2022
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 that the patient was undertaking normal activities and noticed a red area in the lower right quadrant (redness at the infusion site).No patient injury was reported.
 
Manufacturer Narrative
Other, other text: product information was updated.
 
Event Description
It was reported that the participant was undertaking normal activities and noticed a red area in the lower right quadrant (redness at the infusion site).Not otherwise unwell.No patient injury reported.
 
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Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section G)
NULL
MDR Report Key14599320
MDR Text Key294584579
Report Number3012307300-2022-10721
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
Type of Report Initial,Followup,Followup
Report Date 04/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Lot Number3296571
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/16/2023
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) Other;
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