MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	425860405
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a transpac® iv monitoring kit neonatal, 24", disposable transducer, 30 ml squeeze flush (infusion pump) where the customer reported that they had 5 defective kits that were leaking at the yellow piece.It was noted that the nicu team tried multiple times and had the same issue each time.There event was noted during infusion, the transducer were infusing into an umbilical arterial catheter (uac).Additionally, there were no holes, cuts, tears or any defect noted.Harm was not reported as consequence of this event.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.Additional contact information: (b)(6).
Additional Manufacturer Narrative
The reported complaint leaks was not confirmed on the returned set.An image was provided by the customer showing the involved device.No visual anomalies were observed on the returned sets.All the sets were primed and pressure leak tested and no leaks were observed.The product had performed per the specifications.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC® IV MONITORING KIT NEONATAL, 24", DISPOSABLE TRANSDUCER, 30 ML SQUEEZE
• 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: 21996719
• Report Number: 9617594-2025-00969
• Device Sequence Number: 9446984
• Product Code: DRS
• UDI-Device Identifier: 00840619039578
• UDI-Public: (01)00840619039578(17)270801(10)14121332
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 425860405
• Device Lot Number: 14121332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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