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 Material Rupture (1546); No Flow (2991)

Patient Problem Discomfort (2330)

Event Date 07/27/2023

Event Type  Injury  

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.

Event Description

The event involved a transpac¿ iv monitoring kit, disposable transducer, 3ml squeeze flush device, macrodrip, where it was reported the fluids could not be injected into the patient due to a rupture of catheter.This caused patient discomfort or an uncontrolled condition, and had to extend their hospital stay.There was patient involvement and unknown patient harm.No additional information available.

Manufacturer Narrative

No product samples, videos, or photographs were returned for investigation.The lot history was reviewed and there were no nonconformities found 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.

• 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: 17645399
• MDR Text Key: 322214970
• Report Number: 9617594-2023-00607
• 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: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• 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: 09/05/2023
• 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
• Treatment: UNSPECIFIED FLUID, UNK MFR
• Patient Outcome(s): Hospitalization