MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA FOLEY CATHETER SILICONE COATED

Model Number 123518A

Device Problem Dent in Material (2526)

Patient Problems Discomfort (2330); Irritability (2421)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the bedridden patient complained of discomfort using 2-way 18 french catheter.The first batch lot number myen4057 purchased december 2020.The patient felt a discomfort, irritation and the urine were not indwelling properly.Upon assessment, they noticed that the balloon was not equally inflated.Representative learned that patient¿s caregiver was practicing the proper way of inflating the balloon.The customer ordered another box of 2way fr18 with different lot number, but still the same concern.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive because of poor sample condition.Based on the attached photo, the reported event could not be confirmed due to poor sample condition.A potential root cause for this failure mode could be due to low latex viscosity causing thin sac.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: ''caution: this product contains natural rubber latex which may cause allergic reactions.Sterile unless package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon burst.Store catheters at room temperature away from direct exposure to light, preferably in the original box.Single patient use only.Do not reuse and resterilize.For urological use only.Use luer slip syringe.Do not use needle.Visually inspect the product for any imperfections or surface deterioration prior to use.Do not use if package opened or damage.Recommended inflation capacities: 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water do not exceed recommended capacities to deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe "stick" in the valve.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 permitted by hospital protocol, the valve arm may be severed.If this fails, contact and adequately trained professional for assistance, as directed by hospital protocol." the actual/suspected device was inspected.

Event Description

It was reported that a bedridden patient who had been using our 2way fr18 since (b)(6) 2020 recently complained of discomfort by using it.The first catheter with complaint was purchased on december 2020.It was reported that the patient felt discomfort, irritation and the urine was not indwelling properly.Upon assessment, it was noticed that the balloon was not equally inflated.When the customer contacted to report the situation, the representative probed and learned the customer was practicing the proper way inflating the balloon.The representative requested the customer to inflate an unused catheter and send a photo.The customer ordered another box of 2way foley catheter fr18, but still the same concern.No medical intervention was reported.

• Brand Name: BARDIA FOLEY CATHETER SILICONE COATED
• Type of Device: FOLEY CATHETE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12313547
• MDR Text Key: 266227455
• Report Number: 1018233-2021-04913
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741095108
• UDI-Public: (01)00801741095108
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 123518A
• Device Catalogue Number: 123518A
• Device Lot Number: MYEN4057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/12/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR