MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAMPLING PORT, 10 CC C; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 46115-10

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

The complaint/event occurred on an unspecified date and involved a transpac® iv monitoring kit w/03 ml squeeze flush device, sampling port, 10 cc contamination sheath syringe and admin set.The customer reported that the arterial pressure tubing snapped apart in the middle of the tubing (not near the connection sites) immediately upon use at the hospital.There was patient involvement and no adverse event or human harm.This is the second of four reports.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

• Brand Name: TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAMPLING PORT, 10 CC C
• 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: 18633839
• MDR Text Key: 334847345
• Report Number: 9617594-2024-00083
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00887709082496
• UDI-Public: (01)00887709082496(17)260601(10)13655886
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 46115-10
• Device Lot Number: 13655886
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• 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