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

Model Number	806516
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
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 stated that, normal flow was noticed once the syringe has attached and was never allowed the amount of suggested time of the procedure and instructed to cut the valve off and the syringe was not have the free movement.Per additional information received on 17sep2020, at the time of it's removal, it was the first one ever noticed which looked as if it had a o ring on it.That has gradually migrated back towards the more fluted position.In order to produce that o ring effect it appears the flute somehow rolled backwards.Per additional information via email on (b)(6) 2020,the complainant stated that they allowed the syringe to fill on it's own.They waited for several minutes ,self fill stopped at 7ml and user pulled on it but could remove only 5ml.And also stated that they looked closely it appears like there was a buildup of perhaps calcium.
Additional Manufacturer Narrative
The reported event was unconfirmed, as the problem could not be reproduced.Visual inspection noted one opened (without original package), used silicone foley was received.Visual inspection of the sample noted that there were spots that appeared to calcified in the catheter.The catheter balloon inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and there was no leakage or other issues.The balloon concentricity was observed to be 60:40.The balloon rested for 30 minutes without leaks and passively deflated in 53.0 seconds without issue or cuffing, returning 10ml of solution.A potential root cause for this failure mode was unable to determine because the reported event was unconfirmed.The investigation indicated that the reported issue was not manufacturing or supplier related.Therefore, a device history record review was not required.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.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." the actual/suspected device was inspected.
Event or Problem Description
It was reported that the silicone foley had an issue with ridges or cuffing at the balloon area, resulting in some discomfort.  no medical intervention was reported.The balloon apparently ruptured and slide out.The patient stated, normal flow was noticed once the syringe has attached and was never allowed the amount of suggested time of the procedure and instructed to cut the valve off and the syringe was not having the free movement.Per additional information received on 17sep2020, at the time of its removal, the first one ever noticed which looked as if it had an o ring on it.The catheter gradually migrated back towards the more fluted position.In order to produce that o ring effect it appears the flute rolled backwards.Per additional information via email on 06oct2020, the complainant stated that they allowed the syringe to fill on its own.They waited for several minutes, self fill stopped at 7ml and the user pulled on it, but could remove only 5ml.And also stated that they looked closely it appears like there was a buildup of calcium.

• Brand Name: BARDIA ALL-SILICONE FOLEY CATHETER
• Common Device Name: BPCD ALL SILICONE CATHS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10766498
• Report Number: 1018233-2020-20578
• Device Sequence Number: 14268256
• 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): 02/05/2021

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: 11/26/2024
• Device Model Number: 806516
• Device Catalogue Number: 806516-BARD
• Device Lot Number: NGDY3161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 03/02/2021
• 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