MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER; DRAIN BAG

Catalog Number	154004
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the tubing of the drain bag was bent restricting the flow of urine.
Additional Manufacturer Narrative
The reported issue was confirmed.The device was returned and visually inspected.During the visual evaluation a bending tube mark on the drainage tube was observed.In the functional evaluation, water was passed through the drainage tube and there was no obstruction.The bend did not restrict the water flow in the drainage tube.The diameter was measured and it was observed that the bend reduced a15% of the kink and was within specification.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or damaged or if any imperfection or surface deterioration is observed, do not use." (b)(4).
Event or Problem Description
It was reported that the tubing of the drain bag was bent, and restricted the flow of urine.

• Brand Name: BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER
• Common Device Name: DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7045382
• Report Number: 1018233-2017-06004
• Device Sequence Number: 11077854
• Product Code: KNX
• UDI-Device Identifier: 00801741029585
• UDI-Public: (01)00801741029585
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2018

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: Lay User/Patient
• Device Catalogue Number: 154004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 12/23/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1