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 Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 01/04/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to return for evaluation.The device has not been received.

Event Description

The event involved a tego® connector where the patient¿s line became disconnected from the tego during dialysis, resulting in blood loss and required an emergency visit.On (b)(6) 2020, around 1630hr the patient called out reporting they were not feeling well.It was discovered the venous line had separated from the tego of the cvc (central venous catheter) and the tego was still attached to the cvc.The customer reported that 700ml of normal saline was infused and at 1650hr, the patient was transported to (b)(6) ((b)(6) hospital) by ems with a stable blood pressure.The tego had been used on the patient since (b)(6) 2019, 5 days.There was no kink or defect noted on the device.No additional information available.

Manufacturer Narrative

H10 - one used list# d1000, tego¿ connector, lot # 4134681 was received for evaluation.The tego was returned with thread post damage from being bent and seal tearing damage adjacent to the damaged thread post.The probable cause of the thread post and seal tearing damage is typical of over-tightening and/or bending of a mating device at the tego connection during use.The dfu states: attach administration device or syringe by pushing straight to tego access device for infusion.Do not overtighten.The used tego was able to be securely connected to test equipment and met pressure and vacuum leak expectations outlined in the product performance specification.The device history review (dhr) for lot 4134681 and relevant commodities was reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• 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
• MDR Report Key: 9648810
• MDR Text Key: 187698322
• Report Number: 9617594-2020-00029
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)240601(10)4134681
• Combination Product (y/n): N
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• 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: 4134681
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPEC CENTRAL VENOUS CATHETER, MFR UNK.