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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The complaint/event involved a transpac® iv kit w/03 ml squeeze flush device, pt tubings, 3 3-way stopcocks and 36" admin set.Leaks were reported in the tubing of the device during use on a patient.The location of the leak was near the small hole (and unspecified fluid was shooting out of that hole).There was no adverse event or patient harm.
Additional Manufacturer Narrative
D9 - date returned to mfg: 1 may 2025 investigation summary the reported complaint of leak was not confirmed.An image of the drawing was provided by the customer showing the area of the assumed breakage.No visual anomalies were observed on the returned set.When the returned set was primed and pressure leak tested, 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 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: 22021978
• Report Number: 9617594-2025-00998
• Device Sequence Number: 20993027
• Product Code: DRS
• UDI-Device Identifier: 00887709075344
• UDI-Public: (01)00887709075344(17)271201(10)14244856
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 14244856
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED FLUID, MFR UNK.
• Patient Sex: Unknown