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

Model Number	772414
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 experienced a urinary tract infection following use of the catheter.The tray was manufactured without the povidone-iodine pre-saturated swabsticks due to a market wide shortage.The patient allegedly felt that the lack of povidone-iodine pre-saturated swabsticks within the tray contributed to the urinary tract infection.The uti was reportedly treated with antibiotics.
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: ¿after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.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.Lubricate catheter which is pre-attached to collection bag.7.Bag and catheter may be placed in basin until needed.8.Prep patient with povidone-iodine swabsticks.9.Proceed with catheterization in usual manner.10.Top tray may be placed on basin to help prevent spillage.11.Periodic observations of this system should be made to assure that urine is flowing freely.If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed." patient code: (b)(4).
Event or Problem Description
It was reported that the patient experienced a urinary tract infection following use of the catheter.The tray was manufactured without the povidone-iodine pre-saturated swabsticks due to a market wide shortage.The patient allegedly felt that the lack of povidone-iodine pre-saturated swabsticks within the tray contributed to the urinary tract infection.The uti was reportedly treated with antibiotics.

• 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: 8216817
• Report Number: 1018233-2019-00095
• Device Sequence Number: 1593033
• Product Code: KOD
• UDI-Device Identifier: 00801741030406
• UDI-Public: (01)00801741030406
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2019

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: 772414
• Device Catalogue Number: 772414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/01/2019
• 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: Required Intervention