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 Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

The device is not available for further evaluation.The lot number was not reported, therefore, no manufacturing or expiration dates are available.No device history was performed due to there being no lot information available.

Event Description

It was reported that a patient was due for a weekly change of tego.Upon removal of the tego connector, the user had difficulty removing the tego connector and it seemed to be stuck on the dialysis catheter.The user tried to remove it and the outer silicon cover came off.Upon several attempts, the tego connector broke and partial part of the connector was stuck to the dialysis catheter.The patient was then sent to the hospital to get the catheter replaced.The catheter was replaced without further incident.No additional information is available at this time.

• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: christopher zanoni ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 9162660
• MDR Text Key: 204570986
• Report Number: 9617594-2019-00334
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2019

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: D1000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 10/07/2019
• 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