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 Split, Cut or Torn (4008)

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

Event Date 10/22/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, however, has not yet been received.Additional reporter: (b)(6).

Event Description

The event involved a tego® connector where it was reported the tego cap at the end of patient¿s central venous catheter (cvc) was discovered to be torn at the connection site.There was patient involvement and no patient harm.

Manufacturer Narrative

A single used d1000 tego connector was returned with seal tearing confirmed above the thread post on one side and body damage/breakage confirmed along the top rim adjacent to the thread post.The damage rendered the sample unable to be functionally tested.No mating devices were returned to evaluate with the used d1000 tego connector.The probable cause of the damage to the used d1000 tego connector is typical of damage sustained during use due to off-center insertion and overtightening.The dfu states: attach administration device or syringe by pushing straight to tego access device for infusion.Do not overtighten.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9 device returned to manufacturer on 11/21/2023.

• 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
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18161040
• MDR Text Key: 328416569
• Report Number: 9617594-2023-00993
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)280601(10)13684637
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• 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: 13684637
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2023
• 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
• Treatment: CENTRAL VENOUS CATHETER, UNK MFR