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

Model Number 806518

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Tissue Breakdown (2681); Not Applicable (3189); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/07/2021

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 patient's urethra was tear from using the silicone foley catheter.Also, reported that there was some bleeding because the ribbed balloon was too big.The patient used the 16 fr catheter in the past, but wanted to try a larger catheter to help in the improvement in drainage.It was confirmed that the balloon was not pretested prior to insertion to which, mss had advised that pretesting the catheter was not recommended as this could form ridges on the balloon and cause the urethral damage.It was suggested to use a smaller size catheter as 18 fr might be too large.Per follow-up via phone on 14jan2021, no medical intervention was required.The patient reportedly had light bleeding for a couple of days and then cleared up.The customer was no longer using the catheters.

Manufacturer Narrative

The reported event was inconclusive.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.No sample was returned for evaluation.A potential root cause for this failure could be due to "incorrect catheter size selected/inadequate design and /or process".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 petrolatum base.They will damage latex and may cause the balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip tip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 30cc balloon: use 35ml sterile water do not exceed recommended capacities.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.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 permitted by hospital protocol, the valve arm may be severed.If this fails, 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.Visually inspect the product for any imperfections or surface deterioration prior to use." the device was not returned.

Event Description

It was reported that the patient's urethra was tear from using the silicone foley catheter.Also, reported that there was some bleeding because the ribbed balloon was too big.The patient used the 16 fr catheter in the past, but wanted to try a larger catheter to help in the improvement in drainage.It was confirmed that the balloon was not pretested prior to insertion to which, mss had advised that pretesting the catheter was not recommended as this could form ridges on the balloon and cause the urethral damage.It was suggested to use a smaller size catheter as 18 fr might be too large.Per follow-up via phone on 14jan2021, no medical intervention was required.The patient reportedly had light bleeding for a couple of days and then cleared up.The customer was no longer using the catheters.

• Brand Name: BARDIA ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11236006
• MDR Text Key: 228855975
• Report Number: 1018233-2021-00149
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741039188
• UDI-Public: (01)00801741039188
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

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: 806518
• Device Catalogue Number: 806518
• Device Lot Number: NGEV3189
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 05/03/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other