MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® ADD-A-FOLEY TRAY; FOLEY CATHETER TRAY

Model Number	896300
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.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.
Event or Problem Description
It was reported that there were black spots on the inside of the drain bag near the air vent.The drain bag was allegedly positioned flat on the floor and was not allowed to become full.The drain bag was used with a silver coated catheter.No patient injury was reported.
Additional Manufacturer Narrative
The reported issue was confirmed.Visual inspection noted there was foreign material inside the air vent.However; the exact mechanism of the reported failure mode cannot be conclusively determined at this time.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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 if any imperfection or surface deterioration is observed, do not use.Periodic observations of this system should be made to ensure that urine is flowing freely.If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed." (b)(4).
Event or Problem Description
It was reported that there were black spots on the inside of the drain bag near the air vent.The drain bag was allegedly positioned flat on the floor and was not allowed to become full.The drain bag was used with a silver coated catheter.No patient injury was reported.

• Brand Name: BARD® ADD-A-FOLEY TRAY
• Common Device Name: FOLEY CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6776013
• Report Number: 1018233-2017-04151
• Device Sequence Number: 16336651
• Product Code: KNX
• UDI-Device Identifier: 00801741029264
• UDI-Public: (01)00801741029264
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Home Health Aide
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2017

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: Other
• Device Expiration Date: 08/31/2020
• Device Model Number: 896300
• Device Catalogue Number: 896300
• Device Lot Number: NGBQ2194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 09/09/2017
• Initial Report FDA Received Date: 08/08/2017
• Supplement Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1