MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INC. ASPIRA PLEURAL DRAINAGE CATHETER

Catalog Number	4992506
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/23/2017
Type of Reportable Event	Malfunction
Event or Problem Description
During tunneled pleural catheter insertion the catheter was trimmed with the stylet still inside the catheter.This resulted in an unintentional retained foreign object.The stylet remained in the catheter until it was discovered and removed 72 hours later.The stylet is connected to the catheter in such a manner that it appears to be a part of the catheter.The stylet is the same color and material as the catheter making it difficult to see that it is present in the catheter.The instructions included in the kit do not clearly show what the stylet looks like in the diagrams and can easily be confused with a guidewire.If the stylet was made of a different color it would have been more apparent that it had been retained.

• Brand Name: ASPIRA PLEURAL DRAINAGE CATHETER
• Common Device Name: PLEURAL DRAINAGE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS INC.; salt lake city UT
• MDR Report Key: 6797873
• Report Number: 6797873
• Device Sequence Number: 1571155
• Product Code: DWM
• UDI-Device Identifier: 00801741045073
• UDI-Public: 00801741045073
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/27/2017
• Report Date (Section F): 07/27/2017

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: Health Professional
• Device Catalogue Number: 4992506
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/26/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Weight: 68
• Date Report Sent to FDA: 08/14/2017