MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS,; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number	42646-06
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a transpac® iv monitoring kit with safeset¿ reservoir and 2 blood sampling ports, 84" tubing, disposable transducer, 3 ml squeeze flush, macrodrip (pole mount) in which the customer reported that the arterial syringe became separated from the rubber.The event happened during procedure on a patient.There was patient involvement, however, no harm was reported as a consequence of this event.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it is yet to be received.
Additional Manufacturer Narrative
One used list #426460406, transpac® iv monitoring kit with safeset¿ reservoir and 2 blood sampling ports, 84" tubing, disposable transducer, 3 ml squeeze flush, macrodrip (pole mount); lot #5487184 was received for evaluation on 3/30/22.The reported complaint of plunger tip separation is confirmed on the returned set.During visual inspection, the plunger was found detached from the plunger tip.The plunger tip of the safeset reservoir was separated and unable to be pulled back.The probable cause was due to the clips not being fully inserted (engaged) into the mating component during the manufacturing process.Lot history review was performed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS,
• 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: 13941160
• Report Number: 9617594-2022-00067
• Device Sequence Number: 17787397
• Product Code: DRS
• UDI-Device Identifier: 00840619028053
• UDI-Public: (01)00840619028053(17)240701(10)5487184
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 03/11/2022

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: 07/01/2024
• Device Model Number: 42646-06
• Device Catalogue Number: 426460406
• Device Lot Number: 5487184
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 05/03/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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