MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRICATH FOLEY CATHETER

Model Number	0167L22
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed as use related issue.A potential root cause for this failure could be due to "user oversight".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "warning: do not use ointments or lubricants having a petrolatum base.They will damage the catheter.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Contains or presence of natural rubber latex.Caution: this product contains natural rubber latex.Which may cause allergic reactions.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities.3cc balloon: use 5ml sterile water.5cc balloon: use 10ml sterile water.15cc balloon: use 20ml sterile water.20cc balloon: use 25ml sterile water.30cc balloon: use 35ml sterile water.40cc balloon: use 45ml sterile water.75cc balloon: use 80ml sterile water.Do not exceed recommended capacities.For urological use only.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.This is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, ill-ness or death of the patient".
Event or Problem Description
It was reported that the patient had a sentinel event from item 0167l22.Per follow up with the customer via phone on 19jul2021, it was stated that there were somethings that customer was unable to clearly say due to legal but that the patient had a ¿poor outcome¿ after the catheter was placed incorrectly by a nurse.Also stated that they could not specifically blame the outcome only on the catheter placement.They would like for the instructions to be written clearer because it appears that catheter was placed backwards on the patient causing urine to go through the irrigation port.She did specify that the patient had blood clots.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12313689
• Report Number: 1018233-2021-04944
• Device Sequence Number: 3181011
• Product Code: KOD
• UDI-Device Identifier: 00801741018978
• UDI-Public: (01)00801741018978
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2021

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: 0167L22
• Device Catalogue Number: 0167L22
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other