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

Model Number ASU1201

Device Problem Failure to Read Input Signal (1581)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2018

Event Type  malfunction  

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 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.

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
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH; 1500 waukegan road; waukegan IL 60085
• MDR Report Key: 7444161
• MDR Text Key: 106144357
• Report Number: 1423537-2018-00188
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10630140169700
• UDI-Public: 10630140169700
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASU1201
• Device Catalogue Number: ASU1201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2018
• Patient Sequence Number: 1