MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CONECTOR TEGO¿; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number LAT-D1000

Device Problem Fluid/Blood 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.

• Brand Name: CONECTOR TEGO¿
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 12647087
• MDR Text Key: 276867960
• Report Number: 9617594-2021-00281
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00887709096271
• UDI-Public: (01)00887709096271(17)260301(10)5228643
• Combination Product (y/n): N
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• 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 Received: 10/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LAT-D1000
• Device Lot Number: 5228643
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VENOUS LUMEN, MFR UNK
• Patient Age: 67 YR