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

Catalog Number LAT-D1000

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

No product samples were returned for investigation, however a photograph was provided and evaluated.The photo shows two tegos.Leakage is evident from under the seal of one tego.The exact source of the leak is not clear from the image provided.No other damage or anomalies can be seen.The device history review for lot number 4080906 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.Based on the photo provided, the reported complaint of leakage can be confirmed.Without a returned sample a probable cause cannot be determined.

Event Description

The customer stated a patient was admitted to the hemodialysis room, wandering on her own, subsequent discharged from therapy in adequate conditions, without complications or events.The patient was bleeding from the vascular access that impregnated the orifice gauze and the one that covered the catheter lumens.Under aseptic technique, the access was checked, it was noted a healthy orifice, without leakage of lumens; however, the tego rubber had a slight blood drip that increased with mobilization.The clamps were closed, althorugh the catheter material was already evidenced worn out.The lumens were left with the luer lock, covered with sterile material, gauze, and fixomull.The patient stayed under clinical observation, but no further bleeding was evident.There event occurred during patient use, but no adverse event was reported and no one was harmed as a result of the event.

• Brand Name: CONECTOR TEGO
• 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
• Manufacturer Contact: christopher zanoni ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 10152988
• MDR Text Key: 202975585
• Report Number: 9617594-2020-00176
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00887709096271
• UDI-Public: (01)00887709096271(17)240501(10)4080906
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K053106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LAT-D1000
• Device Lot Number: 4080906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• 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
• Patient Age: 56 YR