MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® CLOSED SYSTEM FOLEY CATHETER TRAY; DRAIN BAG

Model Number	802016
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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 bag was missing the part that screws onto the catheter making the device unusable.No medical intervention was required.
Event or Problem Description
It was reported that the bag was missing the part that screws onto the catheter making the device unusable.No medical intervention was required.
Additional Manufacturer Narrative
This report is being submitted past the regulatory timeframe.Please see attached letter for additional information.The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿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.1.Open csr wrap to form sterile field.2.Place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position fenestrated drape on patient.5.Open lubricant/lubricate catheter.6.Open pvi swabstick package and insert into large cutout along box shelf.7.Prepare patient with pvi swabsticks.8.Proceed with catheterization in usual manner.To inflate catheter, simply insert tip of water-filled syringe gently into valve (do not over-penetrate) and depress plunger.Instill entire amount of sterile water (10cc).9.Position hanger near the foot of the bed and check tubing frequently to ensure no freestanding urine.10.To empty bag: a.Remove outlet tube from outlet tube protector.B.Release clamp and empty bag.C.After emptying, clamp outlet tube and replace in outlet tube protector.11.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.12.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 tubing for physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed.Note: bag should be placed near the foot of the bed.".

• Brand Name: BARDIA® CLOSED SYSTEM FOLEY CATHETER TRAY
• Common Device Name: DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8494996
• Report Number: 1018233-2019-01782
• Device Sequence Number: 16740215
• Product Code: EZC
• UDI-Device Identifier: 00801741019678
• UDI-Public: (01)00801741019678
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2019

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 Model Number: 802016
• Device Catalogue Number: 802016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/09/2019
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1