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

Model Number 0165SI18

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2022

Event Type  malfunction  

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 Description

It was reported that the foley catheters kept clogging on patient.

Event Description

It was reported that the foley catheters kept clogging on patient.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be due to wrong duration setting on air purging/plc failure.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: ''warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.Proper techniques for urinary catheter maintenance 1) secure the foley catheter.Use the statlock® foley stabilization device if provided.2) maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions.3) maintain unobstructed urine flow and keep the catheter and collection tube free from kinking.4) keep the collection bag below the level of the bladder or hips at all times.5) empty the collection bag regularly using a separate, clean collection container for each.Foley catheter removal 1) to deflate catheter balloon: gently insert a luer lock or slip tip syringe in the catheter valve.Never use more force than is required tomake the syringe ¿stick¿ in the valve 2) 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 3) use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation 4) if the balloon will not deflate and if permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol 5) should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.'' the device was not returned.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13869930
• MDR Text Key: 287810273
• Report Number: 1018233-2022-01511
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016769
• UDI-Public: (01)00801741016769
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: 0165SI18
• Device Catalogue Number: 0165SI18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 07/15/2022
• Supplement Dates FDA Received: 07/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male