MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. COMPLETE CARE® FOLEY CATHETER TRAY WITH URINE METER; FOLEY TRAY

Model Number	903316A
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	07/14/2017
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.The device was not returned.
Event or Problem Description
It was reported that the patient had drainage impairment shortly after foley placement with a full to relatively full bladder.According to the customer, the directions for use were followed; however, subsequent foleys had to be placed before drainage occurred.
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 states the following: "occlude drainage tubing a minimum of 3 inches below the sampling port by kinking the tubing until urine is visible under the access site.Swab surface of bard ez-lok sampling port with antiseptic wipe.(fig.2) using aseptic technique, position the syringe in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port (at approximately 80 - 100 degree angle).Press the syringe firmly and twist gently to access the sampling port.(fig.3) slowly aspirate urine sample into syringe and remove syringe from sample port.(fig.4) unkink tubing and transfer urine specimen into specimen cup or follow hospital protocol.Discard syringe according to hospital protocol.Follow established hospital protocol for specimen labeling and transport to lab.Sterile: contents of inner wrap are sterile unless package has been opened or damaged.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not re-sterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.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.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use." (b)(4).The device was not returned.
Event or Problem Description
It was reported that the patient had drainage impairment shortly after foley placement with a full to relatively full bladder.According to the customer, the directions for use were followed; however, subsequent foleys had to be placed before drainage occurred.

• Brand Name: BARDEX® I.C. COMPLETE CARE® FOLEY CATHETER TRAY WITH URINE METER
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6775501
• Report Number: 1018233-2017-04134
• Device Sequence Number: 11022637
• Product Code: MJC
• UDI-Device Identifier: 00801741024504
• UDI-Public: (01)00801741024504
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• 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: Health Professional
• Device Model Number: 903316A
• Device Catalogue Number: 903316A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 09/07/2017
• 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