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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUMMINGBIRD MED DEVICES INC SPLIT SEPTUM MICRO T-CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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HUMMINGBIRD MED DEVICES INC SPLIT SEPTUM MICRO T-CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number NMT 8046
Device Problem Fluid Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 11/24/2020
Event Type  No Answer Provided  
Event Description
Leaked at joint in hummi tubing. Assessed line with off going rn in evening, no problems noted. Assessed patient 1 hour later, no problems noted. Infant became fussy (is normally a fussy baby), and another nurse was called to the room to comfort him while i was busy with my other baby. After a few minutes, the rn noted fresh spots of blood appearing on bedding that were not there before and frank blood backing up in the red lumen of the double lumen picc line. Line was flushed with ns but blood returned almost immediately and was visibly leaking from the hub of the hummi device attached to the end of the picc line. Hummi had not been used for blood draws since infant has been in this unit. Hummi was removed from picc line and a t-piece put on in its place when the line was changed shortly thereafter. The device was sent to manufacturer. This is all information available on this event.
 
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Brand NameSPLIT SEPTUM MICRO T-CONNECTOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
HUMMINGBIRD MED DEVICES INC
1283 elger bay road ste d
camano island WA 98282
MDR Report Key11257821
MDR Text Key229590519
Report Number11257821
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberNMT 8046
Device Lot Number19293
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/19/2021
Event Location Hospital
Date Report to Manufacturer02/01/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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