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

Catalog Number 011-D1005

Device Problem Disconnection (1171)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

He device is expected to be returned for evaluation, however, it it not yet received.Section e1 - phone number - (b)(6).

Event Description

The event occurred on an unspecified date and involved a tego® connector which was reported to have had an unspecified problem.The reporter stated that the unspecified condition could lead to life-threatening bleeding.The customer stated that there was patient involvement, and unknown harm.Additional information was received on 14 november, 2023, and the customer stated there was a case where a patient was on dialysis, and there was a disconnection with tego connector and permcathcatheter.This new model of tego plug detached, causing relevant acute hemorrhage and relevant hemoglobin being effected due to hemorrhage.No information was provided as to whether or not medical intervention was necessary.

Manufacturer Narrative

The complaint of broken on item 011-d1005 cannot be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.Lot history review could not be performed due to lot number r16084 shared for this complaint doesn't exist, therefore the lot for this complaint is unknown.

• 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: 18315253
• MDR Text Key: 330589038
• Report Number: 9617594-2023-01133
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-D1005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/29/2023
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: PERMCATHCATHETER, MFR UNK
• Patient Age: 79 YR
• Patient Sex: Male