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

Model Number	806516
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the silicone foley had issue with ridges or cuffing at the balloon area, resulting in some discomfort.No medical intervention was reported.The balloon apparently ruptured and slid out without knowing.The patient noticed there was a normal flow once the syringe was attached and never allowed the time suggested for the procedure.It was then instructed to cut the valve off and the syringe did not have a free movement.Additional information received on 17sep2020, indicated that there was a o ring noticed during the time of removal and it gradually migrated back towards the more fluted position.Also suggested that to produce that o ring effect, it appears the flute somehow rolled backwards.
Event or Problem Description
It was reported that the silicone foley had issue with ridges or cuffing at the balloon area, resulting in some discomfort.No medical intervention was reported.The balloon apparently ruptured and slid out without knowing.The patient noticed there was a normal flow once the syringe was attached and never allowed the time suggested for the procedure.It was then instructed to cut the valve off and the syringe did not have a free movement.Additional information received on 17sep2020, indicated that there was a o ring noticed during the time of removal and it gradually migrated back towards the more fluted position.Also suggested that to produce that o ring effect, it appears the flute somehow rolled backwards.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley.Visual inspection of the sample noted that upon receipt, the balloon was mushroomed.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) without leaks, indicating the balloon had not burst.The balloon rested for 30 minutes without leaks and passively deflated in 56.0 seconds without issue or cuffing, returning 10ml of solution.A potential root cause for this failure could be "balloon material does not shrink quickly enough".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: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile: unless package is opened or damaged.Warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause 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 use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip 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.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.Bard and bardex are registered trademarks of c.R.Bard, inc.Or an affiliate.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.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.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." h11:section a through f - the information provided by bd represents all of 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 ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10656470
• Report Number: 1018233-2020-20033
• Device Sequence Number: 2792922
• Product Code: EZL
• UDI-Device Identifier: 00801741039171
• UDI-Public: (01)00801741039171
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/18/2024
• Device Model Number: 806516
• Device Catalogue Number: 806516
• Device Lot Number: NGDY2761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other