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

Model Number	782100
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 the 10cc sterile water syringe was missing from the tray.
Event or Problem Description
It was reported that the 10cc sterile water syringe was missing from the tray.
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: ¿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 lubricant.Lubricate catheter.7.Pour cleansing solution onto prep balls.8.Prep patient with saturated prep balls.9.Proceed with catheterization in usual manner.10.If specimen is required, fill sterile container from catheter.11.Top tray may be placed on basin to help prevent spillage.12.If urine is placed in specimen jar: a.Secure cap.B.Label specimen jar.C.Send specimen to laboratory.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.Bard and uro-prep are trademarks and/or registered trademarks of c.R.Bard, inc.Volume on collection container has been calibrated without uro-prep tray in place.".

• Brand Name: BARD® FOLEY CATHETERIZATION TRAY URO-PREP¿ TRAY
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8271048
• Report Number: 1018233-2019-00383
• Device Sequence Number: 1617073
• Product Code: KNX
• UDI-Device Identifier: 00801741029622
• UDI-Public: (01)00801741029622
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/20/2019

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 Model Number: 782100
• Device Catalogue Number: 782100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1