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

Catalog Number D1000

Device Problem Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 10/31/2020

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation.It has not been received.

Event Description

The event involved a tego connector.The customer stated that the tego had ¿degeneration of seal on bung, breakdown of outer plastic as well as the inner mechanism, unable to flush once broken.¿ there was blood loss of one whole circuit, roughly 200 mls.The patient¿s hemoglobin level was 101.The medical interventions required was the ¿wash back of the machine, new machine was set up, loss of blood.¿ the tego was in use for less than 10 minutes.The setup was described as the tego was cleaned, lock off of line drew back through the bung, line was flushed, and then attached to hemodialysis machine.No other information was provided.This report is for the first of two events.

Manufacturer Narrative

The device was not returned for evaluation.Without the returned device a probable cause is unable to be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional information in section d9.

• Brand Name: TEGO CONNECTOR
• 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: 10940829
• MDR Text Key: 219573279
• Report Number: 9617594-2020-00520
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)250301(10)4775688
• 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,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D1000
• Device Lot Number: 4775688
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 3 YR