MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 30-CE18SF

Device Problem Difficult to Advance (2920)

Patient Problem Pain (1994)

Event Date 07/25/2017

Event Type  malfunction  

Event Description

Difficult to advance the catheter with the potential for a pneumothorax.While advancing the catheter patients describe more pain than expected.

• Brand Name: CARDINAL HEALTH
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1500 waukegan rd; waukegan IL 60085
• MDR Report Key: 6990450
• MDR Text Key: 90701366
• Report Number: 6990450
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 30-CE18SF
• Device Catalogue Number: 30-CE18SF
• Other Device ID Number: SAFE CENT 8 FRX5CATH MERIT PK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR