MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ASPIRA PLEURAL DRAINAGE TRAY 1L; PATIENT CARE SUCTION APPARATUS

Model Number	4992507
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
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, at this time, for evaluation.A lot history review (lhr) of rebv0850 showed no other similar product complaint(s) from this lot number.Device not returned yet.
Event or Problem Description
It was reported by the sales rep that the facility reported that the cuff of the aspira became detached during tunneling.

• Brand Name: ASPIRA PLEURAL DRAINAGE TRAY 1L
• 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: 7087988
• Report Number: 3006260740-2017-02192
• Device Sequence Number: 1895570
• Product Code: DWM
• UDI-Device Identifier: 10801741091152
• UDI-Public: (01)10801741091152
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K110409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2017

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 Expiration Date: 06/30/2019
• Device Model Number: 4992507
• Device Catalogue Number: 4992507
• Device Lot Number: REBV0850
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1