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

Catalog Number	802100
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 device was not returned.
Event or Problem Description
It was reported that gloves and syringes were missing from the urethral insertion trays.
Additional Manufacturer Narrative
The reported event could not be confirmed.It was unknown whether the device had met specifications due to no sample was returned for evaluation.The product was used for treatment purposes.A potential failure mode could be ¿missing components¿ with a potential root cause of "machine speed out of parameters".This failure falls in a quad 1 risk region and based on this information the risk is low.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: ¿802100 sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Sterilized using ethylene oxide manufacturer: c.R.Bard, inc.Covington, ga 30014 usa 800-526-4455 www.Bardmedical.Com urethral catheter tray single use only.Do not resterilize.For urological use only.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Pk7645230 09/2017 contents: cleansing swab sticks.Waterproof underpad.Drape.Specimen container and label.Gloves (2).5g lubricating jelly.Peel-top tray.Peel apart.Directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.1.Remove tray lid.2.Place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position drape on patient.5.Open lubricant.Lubricate catheter.6.Open packet of swabs.7.Prep patient with swabs.8.Proceed with catheterization in usual manner.9.If specimen is required, fill sterile container from catheter.10.If urine is placed in specimen jar: a.Secure cap.B.Label specimen jar.C.Send specimen to laboratory.Bard and bardia are registered trademarks of c.R.Bard, inc.Warning: after use, the 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.Without catheter one unit released".H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
Event or Problem Description
It was reported that gloves and syringes were missing from the urethral insertion trays.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY
• Common Device Name: URETHRAL TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10038220
• Report Number: 1018233-2020-03092
• Device Sequence Number: 14165297
• Product Code: KNX
• UDI-Device Identifier: 00801741051180
• UDI-Public: (01)00801741051180
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2020

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: Lay User/Patient
• Device Catalogue Number: 802100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2020
• Supplement Date Received by Manufacturer: 05/10/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 05/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1