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 Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.

Event Description

The device involved a tego¿ connector that leaked during patient use.The customer reported that when removing the lines, the transparent material of the tego stopper pulled back slightly causing leakage of blood (less than 20ml approximately) from the limbs of the catheter.The device was in place since (b)(6), 2021.There was patient involvement, however, there was no patient injury associated with this event.The patient recovered and there was no medical intervention associated with this incident.This is report 1 of 2.

Manufacturer Narrative

Two d1000 tego connectors were returned.The was no visual damage or anomalies with either of the two d1000 tego connector assemblies.No mating devices were returned to evaluate with the two d1000 tego connectors.Subsequent pressure and vacuum leak testing showed the two d1000 tego connectors to meet pressure and vacuum leak expectations outlined in the product performance specification.The complaint of leakage could not be replicated or confirmed.A device history review of lot# 4968052 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• 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: 11701386
• MDR Text Key: 256709807
• Report Number: 9617594-2021-00132
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)250801(10)4968052
• 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,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• 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: 4968052
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALCOHOLIC CHLORHEXIDINE 0,5%, MFR UNK.; UNSPECIFIED DIALYSIS LINE, MFR UNK.