MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number D1005

Device Problems Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)

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

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not been received.

Event Description

The event involved a tego connector that leaked around the yellow portion of the device.It was reported that 2 hours into the infusion, blood loss was noted.A stat hemoglobin was done and a 0.5 loss in value was found, with the customer reporting less than 50cc blood loss.The dialysis blood lines were attached to the port, the other mating device reported was a 10cc normal saline syringe.There were no holes, cuts, tears or any defects of the device noted.It was also reported the device was noticed to introduce air around the yellow portion during the process of putting the patient on dialysis.

Manufacturer Narrative

H10 - one used list# d1005, tego¿ connector.Lot # 4875056 and one bd syringe, 10 ml.Were received for evaluation.The used d1005 tego connector attached to the 10ml syringe did leak at low pressure and was punctured through the sidewall of the silicone seal proximal of the post/seal interface.There was no evidence of a sharp instrument entry at the top surface the punctured seal.There was no evidence of a sharp instrument entry at the top surface of the seals or at other locations within the assemblies.The probable cause of the puncture cannot be determined.A device history review for lot# 4875056 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.E1 - initial reporter information from the sus voluntary event report is (b)(6) , occupation: risk manager address: (b)(6) , email: (b)(6).Phone: (b)(6).

Event Description

A sus voluntary event report (mw5096427) was received on30-sep-2020 that stated "tego caps have been leaking between the clear screw adaptor and the yellow plunger part.When this occurred, air was able to enter into the patient¿s ij catheter with potential of serious harm to the patient.¿.

• 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: 10471023
• MDR Text Key: 207730682
• Report Number: 9617594-2020-00355
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619069216
• UDI-Public: (01)00840619069216(17)250601(10)4875056
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D1005
• Device Lot Number: 4875056
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1