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); Skin Inflammation/ Irritation (4545)

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 a bedridden patient was using 2way fr18 catheter since january 2020 alleged that the device caused discomfort while using it.This catheter was initially purchased in december 2020 (lot #myen4057).It was reported that the patient experienced 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 that customer was inflating the balloon in proper way.The representative requested the customer to inflate an unused catheter and to send a photo.The customer ordered another box of 2way foley catheter fr18 with different lot # myeu2318, but still had the same concern as above.No medical intervention was reported.

Event Description

It was reported that a bedridden patient has used 2 way 18 french catheter since (b)(6) 2020.It was alleged that the device caused discomfort while using it.The catheter was initially purchased in (b)(6) 2020.It was reported that the patient experienced discomfort or 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 that the customer was inflating the balloon in the proper way.The representative requested the customer to inflate an unused catheter and to send a photo.The customer ordered another box of 2 way foley catheter of 18 french with different lot but still had the same concern as above.No medical intervention was reported.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.The reported failure was able to be reproduced.The product was used for urological care.Based on the attached photos the asymmetrical balloon was observed on the sample.However the exact cause of how and when the problem was occurred could not be determined.The product had caused the reported failure.A potential root cause for this failure mode could be due to low latex viscosity which caused the 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: "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, reseat 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 the tails, contact an adequately trained professional for assistance as detected by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." correction: d, e, f, g 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.H3 other text : the actual/suspected device was inspected.

• Brand Name: BARDIA FOLEY CATHETER SILICONE COATED
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12333861
• MDR Text Key: 267026949
• Report Number: 1018233-2021-05007
• 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): Y
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• 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: 08/17/2021
• Date Manufacturer Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR