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

Model Number	772414
Health Effect - Clinical Code	Incontinence (1928)
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 device was not returned.
Event or Problem Description
It was reported that the catheter would not drain the urine.The complainant alleged that the patient experienced incontinence immediately upon removal of catheter.Additional information has been requested but not yet received.
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: "warning: 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.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.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.Volume on collection container has been calibrated without uro-prep¿ tray in place.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.Close sampling device.Remove plastic tube from back of sampling device.Unclamp catheter and allow remainder of urine to drain into the bag.If urine is placed in specimen jar: secure cap.Label specimen jar.Send specimen to laboratory.Volume on collection container has been calibrated without uro-prep tray in place." (b)(4).
Event or Problem Description
It was reported that the catheter would not drain the urine.The complainant alleged that the patient experienced incontinence immediately upon removal of catheter.Additional information has been requested but not yet received.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER
• Common Device Name: URETHRAL TRAY WITH CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6954067
• Report Number: 1018233-2017-05286
• Device Sequence Number: 505531
• 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: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2017

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: 772414
• Device Catalogue Number: 772414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 10/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1