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

Device Problem Material Separation (1562)

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

Event Date 02/14/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.

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,
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 13941160
• MDR Text Key: 290187900
• Report Number: 9617594-2022-00067
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619028053
• UDI-Public: (01)00840619028053(17)240701(10)5487184
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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