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

Catalog Number 0165SI18

Device Problem Dent in Material (2526)

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

Event Date 08/10/2023

Event Type  malfunction  

Event Description

It was reported that the customer was having issues with out catheters 3 of the lot (nghq2120), one of the lot (nggx2697) and other one of the lot (nggy1118) patient was trying to use catheter and the balloons were not inflating.The balloon on the item was not inflating correctly when in use, patient had no harm.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Manufacturer Narrative

The reported event was inconclusive due to poor sample condition.The potential root cause for this failure mode could be user related (example: under-inflation during use)/ assembly of the balloon to the shaft/ uneven thickness of balloon.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: "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." h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the customer was having issues with out catheters 3 of the lot (nghq2120), one of the lot (nggx2697) and other one of the lot (nggy1118) patient was trying to use catheter and the balloons were not inflating.The balloon on the item was not inflating correctly when in use, patient had no harm.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17632109
• MDR Text Key: 322063842
• Report Number: 1018233-2023-06385
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0165SI18
• Device Lot Number: NGHQ2120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/21/2023
• 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