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

Catalog Number 011-46115-21

Device Problem Disconnection (1171)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Event Description

The event involved a transpac® iv monitoring kit w/03 ml squeeze flush device, microclave®, 03 ml safeset¿ reservoir and blood sampling port where it was reported there was an issue with the arterial transpac line while sampling for first time on a new patient connected to an umbilical line.The neonatal intensive care unit (nicu) nurse drew back the rocket and it detached from the line at the white junction.The transpac line was replaced and no further issue was experienced.There was patient involvement, and delay in therapy.No patient harm was reported.

• Brand Name: TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAF
• 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: 18903174
• MDR Text Key: 337665882
• Report Number: 9617594-2024-00264
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619094010
• UDI-Public: (01)00840619094010(17)260501(10)13649152
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-46115-21
• Device Lot Number: 13649152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2023
• 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: UMBILICAL LINE, UNK MFR