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 Material Integrity Problem (2978)

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

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation.Without the returned device a probable cause is unable to be established.

Event Description

The event involved a connector tego that the customer reported twenty minutes after initiating personal care therapy, 20 ml of blood leakage was noted thought the tego connector.The customer stated it was rolled, so the defective device was changed for another of the same reference number and the therapy was continued without complications.There was patient involvement, however, no report of adverse 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 11065158
• MDR Text Key: 223602734
• Report Number: 9617594-2020-00544
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00887709096271
• UDI-Public: (01)00887709096271(17)250301(10)4756482
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• 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: 4756482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2020
• 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: 64 YR