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
Medical Device Problem Codes	Break (1069); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a transpac® iv monitoring kit w/03 ml squeeze flush device, sampling port, 10 cc contamination sheath syringe and admin set where the customer reported that the arterial pressure tubing was breaking mid line while in use with patient.There was patient involvement and unknown adverse events or unknown human harm.This is the first of three events.
Additional Manufacturer Narrative
The reported complaint of separation was confirmed on the returned set.During visual inspection, the safeset port was found separated from the 12" pressure tubing.When the end of the tubing was microscopically examined, sufficient solvent coverage was observed.The probable cause of the pressure tubing separation is unknown.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, SAMPLING PORT, 10 CC C
• Common Device Name: 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: 19202046
• Report Number: 9617594-2024-00519
• Device Sequence Number: 20821454
• Product Code: DRS
• UDI-Device Identifier: 00887709082496
• UDI-Public: (01)00887709082496(17)260601(10)13655886
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K061573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2026
• Device Catalogue Number: 46115-10
• Device Lot Number: 13655886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown