MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRIFURCATED TRANSPAC® IV MONITORING KIT W/03 ML FLUSH DEVICE, SAFESET¿ RESERVOIR; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-46115-11

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation, however, photos were provided.Investigation is pending.

Event Description

The event involved a 402, trifurcated transpac® iv monitoring kit w/03 ml flush device, safeset¿ reservoir, needleless valves red and blue stripe tbg.The reporter stated the trifurcated iv monitoring kit- safeset syringe became loose during case, causing blood leakage and air tracking back to the patient.No medication was being used with the products.The set was not reprocessed or re-sterilized prior to use.The customer became aware of the issue by obvious blood leak.There was patient involvement, there was delay in therapy, no adverse event and no one is harmed as a result of the reported event.

Manufacturer Narrative

The reported complaint was confirmed based on the images provided.No product samples, videos were returned for investigation.However, images were provided by the customer showing the involved product.A failure mode was not able to be identified with the image provided by the customer.Without the return of the reported sample a probable cause could not be identified.The device history review (dhr) for lot 13655646 was reviewed and no nonconformities were found that would lead to the reported complaint.

• Brand Name: TRIFURCATED TRANSPAC® IV MONITORING KIT W/03 ML FLUSH DEVICE, SAFESET¿ RESERVOIR
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18653126
• MDR Text Key: 334690277
• Report Number: 9617594-2024-00101
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-46115-11
• Device Lot Number: 13655646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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