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 Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2023

Event Type  malfunction  

Event Description

The event involved tego connector, which the customer reported that at the moment of removing the heparin seal prior to connection, it was observed that the silicone of the bioconnector was wrinkled.At the moment of installing the syringe it was not possible to draw blood.The internal part of the silicone was damaged and did not allow the flow of fluids and it was necessary to change the connector.There was patient involvement, however, no harm was reported as a consequence of this event.

Manufacturer Narrative

E1 - extension number - (b)(6).The device was discarded and is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.

Manufacturer Narrative

Two (2) photographs were shared by the customer, showing a tego with damage on the post and on the top seal, no additional damage are observed on the photos.The complaint of holes / cut / torn can be confirmed based on the photos shared by the customer.However, since no product sample was received for investigation and a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The lot history review was reviewed and no non conformities were found that would have led the reported condition on the complaint.

• 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
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18547296
• MDR Text Key: 333522141
• Report Number: 9617594-2024-00051
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00887709096271
• UDI-Public: (01)00887709096271(17)280301(10)13578867
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• 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: 13578867
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• 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
• Patient Age: 15 YR
• Patient Sex: Female