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

Catalog Number	886-42584-05
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.D4, g4: catalog number 886-42584-05 is not sold in the us.Similar device catalog 852-011-42584-05 is sold in the united states.This product was used for the di and 501k.
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a transpac¿ iv monitoring kit, disposable transducer, 3ml squeeze flush device, macrodrip.The device reportedly leaked an unspecified non-chemotherapeutic drug at the connector.There was no physical damage observed on the device.Although there was a patient involved in the event/complaint, there was no harm.
Additional Manufacturer Narrative
D9 - date returned to mfg on 9/5/2024.The reported complaint of leakage was confirmed on the returned set.An image was provided by the customer showing the involved device.No visual anomalies were observed on the returned set.Functional: when the returned set was primed and pressure leak tested (equipment cal id: p-1g-078) per psp.X.Mk, a leak was observed from the walls of the blue housing.When the blue housing was cut open, the gel cup region is observed to be broken/ bent.Corrosion was observed inside the blue housing.The probable cause of the broken gel cup region had occurred due to an error during automation at manufacturing.A device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3ML SQUEEZE FLUSH DEVICE, MA
• 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: 20165828
• Report Number: 9617594-2024-01258
• Device Sequence Number: 12590659
• Product Code: DRS
• UDI-Device Identifier: 00840619097288
• UDI-Public: 00840619097288
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: 886-42584-05
• Device Lot Number: UNKNOWN
• 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: 08/15/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 09/08/2024
• Supplement Report FDA Received Date: 11/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED NON-CHEMOTHERAPEUTIC DRUG, MFR UNK.
• Patient Sex: Unknown