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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONECTOR TEGO¿ SET, ADMINISTRATION, INTRAVASCULAR

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CONECTOR TEGO¿ SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number LAT-D1000
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2021
Event Type  malfunction  
Manufacturer Narrative
No product samples, videos, or photographs were provided for investigation. The lot history was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint. A probable cause cannot be identified based on the information that has been provided.
 
Event Description
The event involved a tego connector that the customer reported a leak of blood secretion from the venous lumen. The leak occurred 10 minutes after starting a hemodialysis session and the pump alarmed for low venous pressures. When checking the alarm it was noted there was the leak of bloody secretion. The connector was changed out for another one of the same reference and therapy continued without complications. There was patient involvement, however, no report of harm.
 
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Brand NameCONECTOR TEGO¿
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12647087
MDR Text Key276867960
Report Number9617594-2021-00281
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K053106
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 09/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberLAT-D1000
Device Lot Number5228643
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2021
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: 10/18/2021 Patient Sequence Number: 1
Treatment
VENOUS LUMEN, MFR UNK
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