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 Material Integrity Problem (2978)

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

Event Date 05/14/2019

Event Type  malfunction  

Manufacturer Narrative

The device is available for investigation.It is yet to be received.

Event Description

The event involved a tego connector that was reported to have blood leaking during dialysis.It was reported that it was the third access for the tego because there wasn¿t adequate flow through the permacath.After inspection of the tego it was reported that the silicone was torn/damaged.The dialysis lines and tego all had to be changed.A dual cap was used on the tego.The customer reported the patient¿s current condition is fine.Additionally, it was reported that the medical professional didn¿t allege that the device contributed to the event.There is no report of adverse event, no medical intervention, no human harm, however there was a delay in treatment.

Manufacturer Narrative

H10: additional information in section b5.D10: the device was returned on june 19, 2019 for testing and investigation.One (1) used list # d1000, tego® connector; lot # 3785073.Tego seal is observed to be torn at the female luer end.The complaint of leakage of the d1000 tego connector was confirmed and the probable cause was due to seal tearing around the perimeter of the tego.Damage to the top edge of the yellow body is typical of contact with a mating device.Dfu states: "attach administration device or syringe by pushing straight to tego access device for infusion." the flow restriction mentioned in the complaint can be caused by the errant adhesive that was observed when disassembled.The probable cause of the errant adhesive is due to a manual assembly error during assembly.The dhr for lot number 3785073 was reviewed and there were no relevant non-conformances found.

Event Description

Additional information was provided on june 21, 2019 that a merit dual cap was used over the tego.

• 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: 8675146
• MDR Text Key: 147240572
• Report Number: 9617594-2019-00164
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026059
• UDI-Public: (01)00840619026059(17)230901(10)3785073
• 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: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• 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: 3785073
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DUAL CAP, UNK MFR; DUAL CAP, UNK MFR