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

Model Number	802016
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
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 patient felt that his urinary tract infections were caused by the iodine being provided separately instead of in the kit.
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: ¿sterile: contents of inner wrap are sterile unless package is opened or damaged.Contents: 802016 16 fr.Silicone-elastomer coated foley catheter - 5cc balloon inf late with 10ml sterile water ¿ 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 latex which may cause allergic reactions.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Bard and bardia are registered trademarks of c.R.Bard, inc.".
Event or Problem Description
It was reported that the patient felt that his urinary tract infections were caused by the iodine being provided separately instead of in the kit.

• Brand Name: BARDIA® CLOSED SYSTEM FOLEY CATHETER TRAY
• Common Device Name: CLOSED SYSTEM CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8270171
• Report Number: 1018233-2019-00372
• Device Sequence Number: 16548370
• Product Code: EZC
• UDI-Device Identifier: 00801741019678
• UDI-Public: (01)00801741019678
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/31/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other