MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, 84", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH DEVI; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	46115-68
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a transpac iv monitoring kit, 84", disposable transducer, 3 ml squeeze flush device, macrodrip un-bonded where the customer reported that saline was dripping out of transducer port near squeeze mechanism.Additionally, the customer reported, that every time it was squeezed to flush, the fluid would just flow out of it.It was unknown whether or not there was patient involvement; harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.
Additional Manufacturer Narrative
The reported complaint of leakage was confirmed on the returned set.During visual inspection, a bad insertion depth was observed between the polyvinyl chloride (pvc) tubing and the winged male luer.When the set was primed and pressure leak tested, a channel leak was observed between the pvc tubing of the drip chamber and the winged male luer.The tubing and the luer tubing pockets were microscopically examined, and it appears that the pvc tubing was not completely inserted into the winged male luer.The probable cause of the leakage had occurred due to the tubing not fully inserted into the winged male luer during the assembly process at ensenada.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC® IV MONITORING KIT, 84", 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: 23577040
• Report Number: 9617594-2025-02174
• Device Sequence Number: 9532996
• Product Code: DRS
• UDI-Device Identifier: 00887709087040
• UDI-Public: 00887709087040
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 46115-68
• Device Lot Number: 14291923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• 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: HEPARIN AND SALINE, MFR UNK.
• Patient Sex: Unknown