MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV W/03 ML SQUEEZE FLUSH DEVICE, 60" MACRO ADMIN SET AND PRESSURE TUBI; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-46106-74

Device Problems Fluid/Blood Leak (1250); Separation Problem (4043)

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

Event Date 02/18/2023

Event Type  malfunction  

Manufacturer Narrative

See b5 section.

Event Description

The event involved a transpac® iv w/03 ml squeeze flush device, 60" macro admin set and pressure tubing (152cm) in which the customer reported that the noted a welding defect at the connection between the pressure head and the infusion liquid inlet tubing.The incident occurred during infusion and a leak was observed following the incident.The device was replaced and the therapy completed.There was patient involvement, however, no harm was reported as a consequence of this event.The device was received for evaluation and investigation was completed on 6/15/23.The reported complaint was confirmed and a separation was observed on the returned device.During visual inspection, the tubing was found separated from the winged male luer.When the tubing pocket was microscopically examined sufficient solvent coverage was observed.The probable cause of the separation had occurred due to coiling of the tubing before the solvent was fully cured during a manual assembly at manufacturing.A device history review could not be conducted because no lot number was provided.

• Brand Name: TRANSPAC® IV W/03 ML SQUEEZE FLUSH DEVICE, 60" MACRO ADMIN SET AND PRESSURE TUBI
• 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: 17232623
• MDR Text Key: 318340728
• Report Number: 9617594-2023-00303
• Device Sequence Number: 1
• Product Code: DRS
• 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: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-46106-74
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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