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	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a transpac® iv monitoring kit, 84", disposable transducer, 3 ml squeeze flush device, macrodrip un-bonded where it was reported 3 ml flush transducer kits have been having occlusion issues.There was patient involvement and no adverse event.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.Possible lot number: 14291923.Mfr date: 03/05/2025.Exp date: 02/01/2028.
Additional Manufacturer Narrative
Investigation summary: the reported complaint of occlusions was not confirmed.No visual anomalies were observed on the returned sets.When the returned sets were primed and pressure leak tested, no leaks were observed.However, an non-conformance report (ncmr) was identified with an occluded male luer.Based on the ncmr, the reported complaint was confirmed even though the returned sets performed per the specifications.

• 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: 22363312
• Report Number: 9617594-2025-01394
• Device Sequence Number: 12834456
• Product Code: DRS
• UDI-Device Identifier: 00887709087040
• UDI-Public: 00887709087040
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: PLOT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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