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

Device Problems Crack (1135); Fluid/Blood Leak (1250); Unable to Obtain Readings (1516)

Patient Problem Discomfort (2330)

Event Date 06/15/2023

Event Type  Injury  

Manufacturer Narrative

The device is not available for return.However, the completion of the investigation is pending.

Event Description

The event involved a transpac¿ iv monitoring kit, disposable transducer, 3ml squeeze flush device, macrodrip.Cracks in the rotating luer-lock (above the squeezing area) were observed that resulted in leakage and ineffective monitoring of a patient's blood pressure.This issue led to patient discomfort and necessitated an extended hospital stay.There was no report of human harm.

Manufacturer Narrative

No product samples or videos were returned for investigation.However, an image was provided by the customer indicating the area of the image.A failure mode was not able to be identified from the image provided by the customer.The device lot history was reviewed and there were no nonconformities identified that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.The reported complaint cannot be confirmed.The lot history was reviewed and there were no nonconformities which would have contributed to the reported complaint.Additional/updated information can be found in g1 and h6 (medical device problem code).

• Brand Name: TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3ML SQUEEZE FLUSH DEVICE, MA
• Type of Device: 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: 17317248
• MDR Text Key: 319102574
• Report Number: 9617594-2023-00371
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619068615
• UDI-Public: (01)00840619068615(17)251101(10)11757804
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 886-42584-05
• Device Lot Number: 11757804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization