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

Model Number	ASU1201
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility for investigation.Once the investigation is completed a follow-up report will be filed.
Event or Problem Description
The customer claims that after priming the device for use, the suction button would not release resulting in continued suction requiring them to replace the system with a new one.It was reported that the patient was not at risk.The complaint device was discarded after the procedure.
Additional Manufacturer Narrative
No sample was received for evaluation therefore 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: PROBE 5MM X 33CM, DISP FIXED
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH; 1500 waukegan road; waukegan IL 60085
• MDR Report Key: 7440293
• Report Number: 1423537-2018-00182
• Device Sequence Number: 1949777
• Product Code: GBX
• UDI-Device Identifier: 10630140169700
• UDI-Public: 10630140169700
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

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: Other Health Care Professional
• Device Model Number: ASU1201
• Device Catalogue Number: ASU1201
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 06/20/2018
• Patient Sequence Number: 1