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

Model Number	802016
Health Effect - Clinical Codes	No Patient Involvement (2645); 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 device was not returned.
Event or Problem Description
It was reported that the lubricating jelly was missing from the catheter tray.
Additional Manufacturer Narrative
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: ¿contents: 5cc silicone elastomer-coated foley catheter, 16 fr.2000ml (approx.Vol.) capacity drainage bag with anti-reflux chamber, sample port, outlet device, durable hook hanger.Lube jelly, povidone iodine (pvi) swabsticks, 10cc prefilled syringe with sterile water (to inflate foley catheter only), walleted powder-free gloves, fenestrated drape, under-buttocks drape, specimen jar, cap and label.Caution: this product contains natural rubber 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.Open csr wrap to form sterile field.Place underpad beneath patient, plastic side down.Put on cuffed gloves.Position fenestrated drape on patient.Open lubricant/lubricate catheter.Open pvi swabstick package and insert into large cutout along box shelf.Prepare patient with pvi swabsticks.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).Position hanger near the foot of the bed and check tubing frequently to ensure no freestanding urine.To empty bag: remove outlet tube from outlet tube protector.Release clamp and empty bag.After emptying, clamp outlet tube and replace in outlet tube protector." the device was not returned.
Event or Problem Description
It was reported that the lubricating jelly was missing from the catheter tray.

• Brand Name: BARDIA® CLOSED SYSTEM FOLEY CATHETER TRAY
• Common Device Name: CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8002068
• Report Number: 1018233-2018-04953
• Device Sequence Number: 1395316
• Product Code: EZC
• UDI-Device Identifier: 00801741019678
• UDI-Public: (01)00801741019678
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 11/30/2018

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 Model Number: 802016
• Device Catalogue Number: 802016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1