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

Catalog Number 123514A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Abrasion (1689); Tissue Breakdown (2681); Localized Skin Lesion (4542)

Event Date 03/29/2023

Event Type  Injury  

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.H3 other text : the device was not returned.

Event Description

It was reported that the customer had seen a decreased quality of the bardia silicone elastomer foley catheters for a long time.Stated that the catheter fall out (batch# mygq5399, batch# mygq5394 and batch# unk).The incident occurred during use.The customer experienced major problems with bardia catheters in both sizes 12 and 14.The catheters could rarely stay for 12 weeks.They often get stuck (batch# mygq5399, batch# mygq5394 and batch# unk).Also stated that the catheters slipped out.The customer also experience that the catheters often cause damage (batch# mygq5399, batch# mygq5394 and batch# unk).Sometimes the cuff was broken, which could indicate something else (batch# mygq5399, batch# mygq5394 and batch# unk).But, the catheters also came out with a cuff (batch# mygq5399, batch# mygq5394 and batch# unk).This applies to almost everyone with bardia catheters.It was not a special batch, it applied to everyone and for a long time.The customer stated that they should be able to take any as a product sample as this had been a problem for a very long time.There was no special carton or batch number.Also stated that they could see a general deterioration in bardia catheters (batch# mygq5399, batch# mygq5394 and batch# unk).They also don't see the same problem when they had silicone catheters or tiemann catheters.It was unknown what medical intervention was provided.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether thethe reported event was inconclusive as no sample was returned for evaluation.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.Potential root cause for this failure mode could be catheter oversize used or insufficient lubricant applied.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: do not use ointments or lubricants having a petrolatum base.They will damage latex.Visually inspect the product for any imperfections or surface deterioration prior to use.¿ use luer tip syringe to inflate with stated ml of sterile water.Or ¿ for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.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 resterilize 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, illness or death of the patient." corrections: f, 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 device was not returned.

Event Description

It was reported that the customer had seen a decreased quality of the bardia silicone elastomer foley catheters for a long time.Stated that the catheter fall out (batch# mygq5399, batch# mygq5394 and batch# mygn2859).The incident occurred during use.The customer experienced major problems with bardia catheters in both sizes 12 and 14.The catheters could rarely stay for 12 weeks.They often get stuck (batch# mygq5399, batch# mygq5394 and batch# mygn2859).Also stated that the catheters slipped out.The customer also experience that the catheters often cause damage (batch# mygq5399, batch# mygq5394 and batch# mygn2859).Sometimes the cuff was broken, which could indicate something else (batch# mygq5399, batch# mygq5394 and batch# mygn2859).But, the catheters also came out with a cuff (batch# mygq5399, batch# mygq5394 and batch# mygn2859).This applies to almost everyone with bardia catheters.It was not a special batch, it applied to everyone and for a long time.The customer stated that they should be able to take any as a product sample as this had been a problem for a very long time.There was no special carton or batch number.Also stated that they could see a general deterioration in bardia catheters (batch# mygq5399, batch# mygq5394 and batch# mygn2859).They also don't see the same problem when they had silicone catheters or tiemann catheters.Medical intervention was unknown.Per follow-up information received from ibc on 06apr2023, stated that they had seen skin lesions often on men when asked regarding negative consequences for the patient.It was unclear whether it is the fault of the bardia catheters, but they felt that it had become more so in recent years.This applied to several different patients but they live in nursing homes.Some were slim and some had higher body mass index.Per follow-up information received from ibc on 03may2023, stated that it was uneven in the number of catheters.They usually just did not last 12 weeks.They usually were changed more frequently.Most often due to blockage in the catheters.Many of the men had also had skin abrasions from these catheters, and thus permanent skin damage.The customer could not answer the number of catheters as they generally saw these problems in almost all but one patient.The problem had been there for a long time.

• 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
• 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: 16779358
• MDR Text Key: 313679667
• Report Number: 1018233-2023-02734
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 123514A
• Device Lot Number: MYGQ5399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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