MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC PROBE 5MM X 33CM, DISP FIXED; CATHETER, IRRIGATION

Model Number ASU1201

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

No sample was received for evaluation therefore we are unable to confirm the issue report.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.

Event Description

The valve system is not working properly.

Manufacturer Narrative

The actual complaint product was requested, but not received for evaluation.The device history record for the reported lot number has been reviewed for conformance to the cardinal health specifications.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.The product dhr conforms to cardinal health specifications.Testing had been performed prior to final packaging and sterilization and met all requirements.We are unable to confirm the issue report.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: PROBE 5MM X 33CM, DISP FIXED
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 7648426
• MDR Text Key: 112869323
• Report Number: 1423537-2018-00218
• Device Sequence Number: 0
• Product Code: GBX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ASU1201
• Device Catalogue Number: ASU1201
• Device Lot Number: 031764
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2018
• Patient Sequence Number: 1