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 06/15/2019

Event Type  malfunction  

Manufacturer Narrative

The device history (dhr) for lot 3795768 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

Event Description

It was reported that a tego connector, attached to a catheter, leaked a clinically significant amount of blood during patient use.The blood was reported to be seen on the pocket dressing of the catheter.The report also indicated that the user facility uses catheters without cclamps due to losing pieces that have been integrated into the design of the catheter being used by the patient.The tego device was reported to have been removed from the catheter and replaced with a catheter closure cap without issue.Although there was patient involvement, no harm was reported.No additional information is known 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: emily arnould, bsn, rn ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 8827133
• MDR Text Key: 204596446
• Report Number: 9617594-2019-00243
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)230901(10)3795768
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 07/01/2019

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 Expiration Date: 09/01/2023
• Device Catalogue Number: D1000
• Device Lot Number: 3795768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2018
• 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