MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV KIT W/03 ML SQUEEZE FLUSH DEVICE, PT TUBINGS, 3 3-WAY STOPCOCKS AND; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	46114-31
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a transpac® iv kit w/35" pt, 6" pt and 3 needleless valves.The customer reported that the device was noted to be cracked with iv fluid spraying out of it.The device was used on a patient, however, there was no harm reported as a consequence of this event.
Additional Manufacturer Narrative
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
The reported complaint could not be confirmed.No product samples, pictures, or videos were received for investigation.Therefore, a comprehensive failure investigation cannot be performed and a cause cannot be determined.A device history record review could not be completed as the lot number was not provided by the customer.Corrected information can be found in b5, d1 - brand name, d4 - catalog #, d4 - primary udi number, d10 concomitant product, e3 - initial reporter occupation, e4 - initial report sent to fda and h6 medical device problem codes.
Event or Problem Description
Additional information was received by the customer on (b)(6) 2025 stating that the device involved was a transpac® iv kit w/03 ml squeeze flush device, pt tubings, 3 3-way stopcocks and 36" admin set.

• Brand Name: TRANSPAC® IV KIT W/03 ML SQUEEZE FLUSH DEVICE, PT TUBINGS, 3 3-WAY STOPCOCKS AND
• 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: 21964652
• Report Number: 9617594-2025-00916
• Device Sequence Number: 20955462
• Product Code: DRS
• UDI-Device Identifier: 00887709075344
• UDI-Public: 00887709075344
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse Practitioner
• 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: 46114-31
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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