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

Catalog Number D1000

Device Problems Fluid/Blood Leak (1250); Air/Gas in Device (4062)

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

Event Date 08/25/2023

Event Type  malfunction  

Event Description

The complaint involved an unspecified tego¿ connector that was reported to have significant air leakage from the arterial line that was connected to the tego.The issue was encountered immediately at the start of a new dialyses session.Although the tego connector and the arterial line were properly connected (and there were no visual issues noted), it seemed most likely to the customer that the excessive air loss was due to a defect in the tego connector.The device was installed on (b)(6) 2023.It occurred during the third time that the tego was used (during the third dialyses treatment).The tego connector was removed on (b)(6) 2023.The patient lost about 100ml of blood.There was no patient harm reported and the patient did not require additional treatment.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The customer provided additional information on (b)(6) 2023 via email stating that the customer was unable to trace the exact lot number of the defective tego.However, they currently have tego¿s from following lot numbers in use at the time of the event: 13506120, 13490327, 13456242, 13514588 and 13514688.The tego was replaced once the leakage was detected.It was unknown if there was any visible damage or issues with the affected product.The event did not prolong the hospital stay of the patient.

Manufacturer Narrative

Additional information can be found in b5 and updated information can be found in g1.

Manufacturer Narrative

One used sample item # d1000 was returned for evaluation.As received, a tear on the top seal was observed.The sample failed the high / low pressure during the inactivated condition.The tego was dissembled and a punctured over the seal surface was found.No mating device was returned.The customer complaint of leaks can be confirmed.According customer complaint description, the issues was observed upon the third day of dialyses treatment.The probable cause was likely caused by a sharp object used during use.According dfu statement - do not use needles, blunt cannulas, or luer caps with the tego.Device history records for the possible lot numbers 13506120, 13490327, 13456242, 13514588 and 13514688 were reviewed, no nonconformities were identified that may have contributed to the reported complaint.Date returned to mfg: 21sep2023.

• 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17711307
• MDR Text Key: 322963691
• Report Number: 9617594-2023-00666
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• 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 ARTERIAL LINE, MFR UNK.