MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT W/SAFESET¿ 84" RED STRIPE ARTERIAL PRESSURE TUBING,; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-46103-94

Device Problem Material Separation (1562)

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

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the extensions breaking was confirmed on the returned set.During visual inspection, the 25" arterial pressure tubing was found separated from the winged male luer.The tubing pocket of the pressure tubing was found tacky.The probable cause of the tubing separation had occurred due to the uv adhesive at the bond between the pressure tubing and the male luer was not fully cured during assembly.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

Event Description

It was reported that right after installation, the extensions broke for no reason.There was no patient harm reported.No additional information is available at this time.

• Brand Name: TRANSPAC® IV MONITORING KIT W/SAFESET¿ 84" RED STRIPE ARTERIAL PRESSURE TUBING,
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 13657799
• MDR Text Key: 291404909
• Report Number: 9617594-2022-00040
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619042639
• UDI-Public: (01)00840619042639(17)240401(10)5214766
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Catalogue Number: 011-46103-94
• Device Lot Number: 5214766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• 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