MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH DEVICE,; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 886-42584-05

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2023

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of leakage was confirmed.No samples or videos were returned for evaluation.However, an image was provided by the customer showing a leak between the pvc tubing and the drip chamber.Without the return of the reported sample, a probable cause could not be determined.The lot history was reviewed and there were no nonconformities which would have contributed to the reported complaint.

Event Description

The event involved a transpac® iv monitoring kit, disposable transducer, 03 ml squeeze flush device, macrodrip where it was reported that there was leakage on connector which may result in patient discomfort or an uncontrolled condition and may have to extend their hospital stay.The solution/medication involved was normal saline.There is unknown patient involvement and unknown patient harm.There was no chemo drug involved and the other information was unknown.

• Brand Name: TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH DEVICE,
• 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: 18437401
• MDR Text Key: 331916134
• Report Number: 9617594-2024-00006
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619068615
• UDI-Public: (01)00840619068615(17)260301(10)13596341
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 886-42584-05
• Device Lot Number: 13596341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2023
• 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: NORMAL SALINE, MFR UNK