MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ASPIRA PLEURAL DRAINAGE CATHETER 15.5F INSERTION TRAY; PATIENT CARE SUCTION APPARATUS

Model Number	N/A
Health Effect - Clinical Codes	Cellulitis (1768); Fluid Discharge (2686); Foreign Body In Patient (2687)
Date of Event	07/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by the facility that the patient had an aspira pleural catheter placed by physician #1, in interventional radiology.It was subsequently removed in interventional radiology by physician #2, on (b)(6) 2016.Patient has had persistent drainage and chest wall cellulitis resulting in consultation with infectious disease, physician recommended antibiotic therapy.Patient has had poor healing and two courses of antibiotics prior to seeing the infectious disease physician, several ct scans were performed during the course of care.Patient has remained on chronic doxycycline over the course of the year.In 2017 the patient identified a fibrinous material at the site.A foreign body in a cylindrical shape was removed from the patients chest wall by physician #3, presumed to be the cuff from the catheter.Provider felt that he had removed the catheter intact.

• Brand Name: ASPIRA PLEURAL DRAINAGE CATHETER 15.5F INSERTION TRAY
• Common Device Name: PATIENT CARE SUCTION APPARATUS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6880020
• Report Number: 3006260740-2017-01652
• Device Sequence Number: 16285410
• Product Code: DWM
• UDI-Device Identifier: 10801741091176
• UDI-Public: (01)10801741091176
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/20/2017
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4992509
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/27/2017