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 Code	Pain (1994)
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 a kinked catheter.The patient allegedly experienced pain.No medical intervention reported.
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: "bard® latex-free urethral catheterization tray with preconnected drain bag 772514 plastic catheter 16 fr.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Contents: plastic catheter, 16 fr., preconnected to closed system collection bag (1000ml approx.Vol.) uro-prep¿ tray with: underpad, drape sterile: contents of inner wrap are sterile unless package is opened or damaged.C.R.Bard, inc.Covington, ga 30014 1-800-526-4455 www.Bardmedical.Com manufactured in mexico povidone-iodine swabsticks (3) specimen container and label graduated collection container latex-free gloves (2) lubricant packet directions for use on reverse side.Single use only.Do not resterilize.For urological use only.".
Event or Problem Description
It was reported that the patient had a kinked catheter.The patient allegedly experienced pain.No medical intervention reported.

• 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: 7880985
• Report Number: 1018233-2018-04196
• Device Sequence Number: 16599174
• 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): 10/15/2018

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?: No
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1