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

Model Number	782100
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported issue could not be confirmed as no sample was returned for evaluation.A potential root cause for this failure could be "incorrect operation".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "contents: uro-prep¿ tray with: underpad, drape povidone-iodine solution npn 02076144 10cc syringe (prefilled with sterile water) to inflate foley catheter only.Latex-free, powder-free gloves(2) specimen container and label lubricant packet, forceps, prep balls (5) graduated collection container.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.Open lubricant.Lubricate catheter.Pour cleansing solution onto prep balls.Prep patient with saturated prep balls.Proceed with catheterization in usual manner.If specimen is required, fill sterile container from catheter.Top tray may be placed on basin to help prevent spillage.If urine is placed in specimen jar: secure cap.Label specimen jar.Send specimen to laboratory.".
Event or Problem Description
It was reported that there was no iodine present in the tray.

• Brand Name: BARD FOLEY CATHETERIZATION TRAY URO-PREP TRAY
• Common Device Name: FOLEY CATHETERIZATION TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10279567
• Report Number: 1018233-2020-04542
• Device Sequence Number: 1073809
• Product Code: KNX
• UDI-Device Identifier: 00801741029622
• UDI-Public: (01)00801741029622
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 07/15/2020

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: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 782100
• Device Catalogue Number: 782100
• Device Lot Number: NGDX4664
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1