MAUDE Adverse Event Report: CARDINAL HEALTH TRUMPET VALVE, NO PROBE,; CATHETER, IRRIGATION

Model Number ASU1220

Device Problems Failure to Read Input Signal (1581); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint was received and forwarded to the manufacturing facility for investigation.The actual complaint product was requested, but not received for evaluation.The device history record for the reported lot has been reviewed for conformance to cardinal health specifications and the product does conform.The product is tested 100% for leaks specifically the ¿aspiration button¿ is depressed, opened and closed several times during the test for leaks, and visual integrity appears to be in conformance.Testing had been performed prior to final packaging and sterilization and met all requirements.We will continue to monitor and if the actual complaint sample becomes available we will reopen the investigation.

Event Description

It was reported that the surgeon was performing a lap chole on and female patient when the trumpet valve would not suction.The red button is either sticking when pushing down or once it¿s been pushed.The patient was not compromised during the procedure and another trumpet valve was pulled from the shelf to finish the case.

Manufacturer Narrative

We are unable to confirm the issue reported.However, cardinal health has become aware of an issue in which the hydroline and pulse wave trumpet valves may not close properly, which could cause continuous suction.There is a remote possibility that inability to control suction during a procedure may result in loss of carbon dioxide in the abdomen, reduced visibility of the surgical site and potential injury to organs and body tissue.Cardinal health has issued a voluntary recall that was initiated on june 11th 2018.

• Brand Name: TRUMPET VALVE, NO PROBE,
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH; 1500 waukegan road; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 1500 waukegan road; waukegan IL 60085
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085
• MDR Report Key: 7468110
• MDR Text Key: 106961718
• Report Number: 1423537-2018-00194
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10630140169779
• UDI-Public: 10630140169779
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: ASU1220
• Device Catalogue Number: ASU1220
• Device Lot Number: 041737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1