MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® FOLEY CATHETERIZATION TRAY URO-PREP¿ TRAY; FOLEY CATH 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 device was not returned for evaluation.A potential failure mode could be " missing components / accessories and/or not according to proper assembly sequence.", 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:¿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.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.".
Event or Problem Description
It was reported that the povidone-iodine was missing from the foley cath tray.The complainant reportedly had additional iodine available to use for catheter insertion.

• Brand Name: BARD® FOLEY CATHETERIZATION TRAY URO-PREP¿ TRAY
• Common Device Name: FOLEY CATH TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8804623
• Report Number: 1018233-2019-04039
• Device Sequence Number: 11436324
• Product Code: KNX
• UDI-Device Identifier: 00801741029622
• UDI-Public: (01)00801741029622
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 07/18/2019

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 Expiration Date: 06/30/2021
• Device Model Number: 782100
• Device Catalogue Number: 782100
• Device Lot Number: NGCU3710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1