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 Fluid/Blood Leak (1250)

Patient Problems Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/15/2022

Event Type  Injury  

Event Description

The event involved a tego® connector that the customer reported to have failed.A patient finished dialysis treatment, washed back, and then tegos cleaned with clinelle wipe, blood was coming out of the lumen via tego.The lumen was then flushed and cleaned with a clinelle wipe and a new tego was attached.The department contacted known users with the advice to use the lines as if there are no tegos in situ and clamp the line whenever the line is disconnected.There was patient involvement, however no report of patient harm.

Manufacturer Narrative

It is unknown if the device will be returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The customer identified two possible lot numbers (plots).The possible lot numbers are 5648558 (expiry date 10/1/2026 , mfr date 10/01/2021), 5470698 (expiry date 06/01/2026, mfr date 06/01/2021).Initial reporter phone number: (b)(6).

Manufacturer Narrative

The device is available for evaluation.Investigation is pending.Additional information in: b1, b2, b5, d9, h1, h3, and h6 d9 device returned to manufacturer on 8/22/2022.

Event Description

Additional information received from the customer stating the patient experienced a cardiac arrest with potential caused by an air embolism.Cardiopulmonary resuscitation (cpr) was performed and patient stayed in the intensive care unit (icu).Blood loss was approximately 1/2 ml.There was no hole, cut, tear or any defect noted.

Manufacturer Narrative

Received one new.List #d1000, tego¿ connector, appx 0.05 ml; lot #5648558 and two used.List #d1000, tego¿ connector, appx 0.05 ml; lot #unknown for evaluation.The complaint of leakage can be confirmed on one (1) of the two (2) returned used list #d1000, tego¿ connector, appx 0.05 ml; lot #unknown.As received there were blood residuals observed in one (1) of the two (2) returned tegos.This same tego a small tear on the rim.Both tegos had no post damages.No tears observed near the top slit of the tego.No damages observed on the sides.The new tego had no damages or anomalies noted.Each of the returned two (2) used and one (1) new tego were leak tested as per product specification.There was a leak observed on one (1) of the returned used tego.The second used and new tego met product specifications.The sample that leaked was disassembled to determine the probable cause of the leakage.Just above the side wings of the seal there was a tear.The tear caused a hole in the lumen leading to the leakage observed during testing.The probable cause of the tear is unknown.The lot history was reviewed on the new #d1000, tego¿ connector, appx 0.05 ml; lot #5648558 and no nonconformities were identified that may have contributed to the reported complaint.

Event Description

Additional information received by the customer on october 17, 2022 stating the cardiac arrest occurred about 2-3 minutes after discontinuing dialysis.The current status of the patient is slow but independent with activities of daily living (adl's).Patient plays golf regularly and drives between holes.

• 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: 14958220
• MDR Text Key: 304512843
• Report Number: 9617594-2022-00200
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D1000
• Device Catalogue Number: D1000
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: UNSPECIFIED CATHETER LINES, UNK MFR.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male