MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ARTERIAL TRANSPAC® IV MONITORING KIT

Model Number 011-46115-14

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The date of the event is unknown.The event involved a customer report stating that when the arterial transpac iv monitoring kit was opened, it was noted that the tubing was disconnected from a fused end near the transducer.After review of the customer provided image, the disconnection occurred at a bonded site located on the pressure tubing.There was no patient involvement.

Manufacturer Narrative

Received one (1) unused, in an open pouch, list # 011-46115-14, arterial transpac® iv monitoring kit; lot # 3481450.As received, the 55" red stripe pressure tubing was separated from the winged female luer.Uv adhesive was observed on the end of the tubing and in the tubing pocket of the female luer; however, the uv adhesive was tacky and appears to not be fully cured.A dhr review was completed and no non conformances were noted.The reported complaint of the tubing separating was confirmed.The probable cause of the failure is that the uv adhesive at the bond between the arterial tubing and female luer was not fully cured.

• Brand Name: ARTERIAL TRANSPAC® IV MONITORING KIT
• Type of Device: ARTERIAL TRANSPAC® IV MONITORING KIT
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, 22790 ; MX 22790
• MDR Report Key: 7682411
• MDR Text Key: 113884230
• Report Number: 9617594-2018-00040
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: 011-46115-14
• Device Catalogue Number: 011-46115-14
• Device Lot Number: 3481450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Date Manufacturer Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1