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

Model Number	ASU1220
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was received and forwarded to the manufacturing facility for investigation.The actual complaint product was requested, but not received at the manufacturer.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 sample becomes available we will reopen the investigation and file a follow-up report.
Event or Problem Description
The suction button kept getting stuck during a prostatectomy procedure.No injury to patient, doctor completed the procedure without incident with another device.
Additional 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,
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH; 1500 waukegan road; waukegan IL 60085
• MDR Report Key: 7503225
• Report Number: 1423537-2018-00196
• Device Sequence Number: 16597669
• Product Code: GBX
• UDI-Device Identifier: 10630140169779
• UDI-Public: 10630140169779
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: ASU1220
• Device Catalogue Number: ASU1220
• Device Lot Number: 101723
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 06/25/2018
• Patient Sequence Number: 1