MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML F; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number	42801-28
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received by the manufacturer, but the evaluation is not yet complete.Initial reporter phone extension (b)(6).
Event or Problem Description
The incident involved a transpac¿ it monitoring kit, 84" safeset reservoir, 2 blood sampling port, 3ml flush device, un-bonded macrodrip on an unknown date.It was reported that there was leaking near the transducer.When pulling back the plunger on the arterial line kit, it cracked off and broke completely apart from the suction part of the syringe.The customer further reported that the right radial arterial line tubing disconnected from a fused point next to the plunger causing arterial blood to back up out of the line and onto the floor.The event occurred during use on patient.There was delay in therapy, but no patient harm was reported.
Additional Manufacturer Narrative
The reported complaint of separation was confirmed on the returned set.During visual inspection, the 25" pressure tubing was found separated from the female luer.The pressure tubing was found tacky at the bond site.The separation of the bond was due to the pressure tubing being tacky.The probable cause of the pressure tubing being tacky is due to the uv adhesive on the tubing not being fully cured during assembly process during manufacturing.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML F
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16495649
• Report Number: 9617594-2023-00094
• Device Sequence Number: 17716284
• Product Code: DRS
• UDI-Device Identifier: 00887709120778
• UDI-Public: (01)00887709120778(17)250301(10)5882018
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• 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,Followup
• Report Date (Section B): 02/13/2023

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: 03/01/2025
• Device Model Number: 42801-28
• Device Catalogue Number: 42801-28
• Device Lot Number: 5882018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2022
• 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