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

Model Number	772415
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.The device was not returned.
Event or Problem Description
It was reported that iodine was missing from five cases of the urethral catheter trays.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use was found adequate and states the following: "bard® urethral catheterization tray 772415 red rubber catheter, 15 fr.Caution: this product contains natural rubber latex which may cause allergic reactions.Contents: **red rubber catheter, 15 fr.Uro-prep¿ tray with: underpad, drape povidone-iodine swabsticks (3) specimen container and label synthetic vinyl gloves (2) lubricant graduated collection container caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.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 catheter manufactured in u.S.A.Single use only.Do not resterilize.For urological use only.Directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.1.Open csr wrap to form sterile field.2.Place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position drape on patient.5.Remove top tray.6.Open lubrication-lubricate catheter.7.Prep patient with povidone-iodine swabsticks.8.Proceed with catheterization in usual manner.9.If specimen is required, fill sterile container from catheter.10.Top tray may be placed on basin to help prevent spillage.11.If urine is placed in specimen jar: a.Secure cap.B.Label specimen jar.C.Send specimen to laboratory.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." 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 iodine was missing from five cases of the urethral catheter trays.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER 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: 7889000
• Report Number: 1018233-2018-04246
• Device Sequence Number: 1862263
• Product Code: KOD
• UDI-Device Identifier: 00801741030413
• UDI-Public: (01)00801741030413
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2018

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 Expiration Date: 01/31/2021
• Device Model Number: 772415
• Device Catalogue Number: 772415
• Device Lot Number: NGCR1112
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/13/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1