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

Model Number D1000

Device Problem Material Integrity Problem (2978)

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

Event Date 02/11/2023

Event Type  Injury  

Manufacturer Narrative

The device has been received for evaluation.Investigation is pending.

Event Description

The event involved a tego connector that broke and stuck inside a central venous catheter (cvc) arterial lumen while trying to replace old tego with a new tego.The problem occurred when the patient was being disconnected from hemodialysis bloodlines at end of treatment and was due for a weekly tego change.Staff was planning to change the old tego out then planning to put in a new tego and flush the line but was unable to remove the old tego (hence why there is some blood on the remnants of the old tego).The staff attempted to change the tego after treatment but found it was stuck inside the patient¿s central line.The staff attempted to untwist it from the central line and attempted implements to improve grip (gloves and clamp) but still unsuccessful at removing tego.No infusion was occurring when tego was attempted to be removed.When the tego was removed, a portion remained stuck inside the patient's central line.As the leftover portion was unable to be removed, that patient had a central line exchange performed.A remnant of tego was dislodged in one of the lumens of the patient's central line, rendering it unusable for hemodialysis treatment (patient is reliant on chronic hemodialysis treatment) and a safety risk for the patient (e.G., the tego remnant could travel father in/out of the catheter lumen at any time and pose bleeding and infection risk to the patient).The patient thus required their now unusable central line to be removed and a new one inserted.The patient has a tunneled central line.In short, the patient had to undergo a surgical procedure typically done with local anesthetic to have their central line exchanged.There were no additional medical interventions required other than replacing the central line and no clinically significant blood loss.There was no delay of critical therapy.There was no report that the patient's status changed throughout the ordeal.They were sent to emergency for observation overnight until a central line exchange could be arranged for the patient the next day; they spent over a half-day at-hospital before being discharged home.The sutures on their new central line will need to be taken out by frontline staff 2 weeks (insertion suture) and 8 weeks (exit site suture) post-insertion.There was patient involvement and adverse event.

Manufacturer Narrative

Received one used.List #d1000, tego¿ connector, appx 0.05 ml; lot #unknown.The complaint of difficulty to remove and cracks can be confirmed on the returned one used tego¿ connector.No mating device was returned for evaluation.There was severe tool damage on the returned tego.The tego was broken in half.The male luer was broken off and not returned.The was no damage to the to female luer side of the tego.The probable cause of the damage observed is due to tools being used to remove the tego during use.The probable cause of the tego being difficult to remove is unknown.A device history review (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16546657
• MDR Text Key: 311327113
• Report Number: 9617594-2023-00107
• Device Sequence Number: 1
• Product Code: FPA
• 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,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D1000
• Device Catalogue Number: D1000
• Device Lot Number: 10230746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2022
• 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; HEMODIALYSIS BLOOD LINES, UNK MFR
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male