MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH DEVI; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	425840405
Medical Device Problem Codes	Break (1069); Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date involving a transpac® iv monitoring kit, 60", disposable transducer, 3 ml squeeze flush device, macrodrip where the customer reported that the current arterial line is defective.It is difficult to disconnect at patient's side and flushing device breaks easily.There was patient involvement and delay in critical therapy.The caregiver changed to another arterial line tubing to address the issue.There was no serious deterioration in the state of health of a patient, user, or other person.There was no death of a patient, user, or other person.There was no potential for death or serious deterioration in health of a patient, user, or other person.
Additional Manufacturer Narrative
E1 - (b)(6).The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A device history review could not be completed due to the unknown lot number.
Additional Manufacturer Narrative
No product samples, videos were returned for investigation.However, an image was provided by the customer showing the label of the product.A failure mode was not able to be identified with the image provided by the customer.Therefore, a comprehensive failure investigation cannot be performed and the complaint cannot be confirmed.The device history report (dhr) for lot 13887280 was reviewed and no non conformities were found that would led to the reported complaint.

• Brand Name: TRANSPAC® IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH DEVI
• 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: 19672170
• Report Number: 9617594-2024-00870
• Device Sequence Number: 6586952
• Product Code: DRS
• UDI-Device Identifier: 00840619027414
• UDI-Public: (01)00840619027414(17)270101(10)13887280
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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 Catalogue Number: 425840405
• Device Lot Number: 13887280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2024
• 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