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 device is not available for investigation.Without the return of the device a probable cause is unable to be determined.If a return or any additional information is later received, then a supplemental emdr will be submitted at that time.The dhr for lot 13596341 was reviewed and no non conformities were found that would have led to the reported complaint.

Event Description

The complaint/event involved a transpac® iv monitoring kit, disposable transducer, 03 ml squeeze flush device, macrodrip.Leakage on tubing was noted when the set was connected to 500ml normal saline.There was no report of human harm.

• 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: 18614296
• MDR Text Key: 334211271
• Report Number: 9617594-2024-00071
• 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
• Type of Report: Initial
• Report Date: 01/31/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 886-42584-05
• Device Lot Number: 13596341
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/31/2024
• 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: 500ML NORMAL SALINE, MFR UNK