MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER; URETHRAL CATHETER TRAY

Model Number	772514
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
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 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 the catheter inside the tray was kinked.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation of the returned sample noted one opened, unused catheter attached to a drain bag.The catheter appeared relatively straight, but was difficult to determine without the original packaging.No obvious bends, deformities or damage to restrict flow were observed.The catheter was flushed with 10 ml of methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water) and flowed through unobstructed.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use was found adequate and states the following: "visually inspect the product for any imperfections or surface deterioration prior to use.Open csr wrap to form sterile field.Place underpad beneath patient, plastic side down.Put on cuffed gloves.Position drape on patient.Remove top tray.Lubricate catheter which is pre-attached to collection bag.Bag and catheter may be placed in basin until needed.Prep patient with povidone-iodine swabsticks.Proceed with catheterization in usual manner.Top tray may be placed on basin to help prevent spillage.Periodic observations of this system should be made to assure that urine is flowing freely.Volume on collection container has been calibrated without uro-prep¿ tray in place.Bard and uro-prep are trademarks and/or registered trademarks of c.R.Bard, inc.©2010 c.R.Bard, inc.All rights reserved.Directions for taking specimen: after catheter has been inserted into the bladder and an initial flow of urine is seen in the collection bag: clamp off catheter using white clamp.Insert plastic tube (inside bag) into the back of the sample device.Open sample device over the sample container.Unclamp catheter.Allow desired amount of urine to drain into collection container.Clamp off catheter.".
Event or Problem Description
It was reported that the catheter inside the tray was kinked.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER
• Common Device Name: URETHRAL CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7895328
• Report Number: 1018233-2018-04337
• Device Sequence Number: 1394957
• Product Code: KOD
• UDI-Device Identifier: 00801741030444
• UDI-Public: (01)00801741030444
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2018

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: Health Professional
• Device Model Number: 772514
• Device Catalogue Number: 772514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1