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 Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not been received.The lot number of the device that was in use is unknown.The customer identified two possible lot numbers (plots).The possible lot numbers are 4047370 (expiry date 04/01/2024 , mfr date 04/01/2019), and 4030802 (expiry date 04/01/2024, mfr date 03/01/2019).

Event Description

The event involved a tego® connector where the fresenius venous line disconnected from a tego connector a few minutes after the start of dialysis.This led to a blood loss of about 200 ml.The patient was checked by a physician following the event, with the patient being stable.There was no defect noted on the affected sample.The device was changed out/replaced with no further problems encountered.There was patient involvement, but no patient harm, or delay in critical therapy reported.

Event Description

Additional information received that the birth year of the patient was 1928.

Manufacturer Narrative

H10 - one used list# 011-d1005, tego¿ connector.Lot# unknown, one new list# 011-d1005, tego¿ connector.Lot# 4030802 and one new list# 011-d1005, tego¿ connector.Lot# 4047370 were received for evaluation.The complaint of disconnection on the one used and two new d1005 tego connector could not be confirmed or replicated.There was no mating device returned for evaluation.There was no disconnection or leakage during functional testing.Each d1005 tego connectors met pressure and vacuum performance expectation outline in the product specification.The male lure of the tego connector and the threads are iso compliant.Each returned d1005 tego met product specifications.A device history review for lot# 4030802 and 4047370 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.Additional information can be found in sections a3 and b5.

• 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: 10696157
• MDR Text Key: 211861726
• Report Number: 9617594-2020-00451
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• 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: PLOTS
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPEC VENOUS LINE, MFR FRESENIUS; UNSPEC VENOUS LINE, MFR FRESENIUS