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

Model Number 175816

Device Problem Decrease in Pressure (1490)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

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 foley catheter from a lot was inserted and fell off, the patient thought that there was a hole in the balloon, and another lot was inserted and the catheter fell off while during the change in the bed linens.Per follow-up via phone on (b)(6) 2020,the balloons were deflated and tried to fill the fluid into the balloon after they fell off and 5 lots of catheters were having holes in them.The fluid was initially used to inflate the balloon was 10ml in all the first 4 catheters and the 5th one alone filled 5ml into the balloon and the catheter was fell off.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "pinhole in balloon or cuff wall thickness too thin".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿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.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage silicone and may cause the balloon to burst.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Unless package is opened or damaged.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 tip syringe.Do not use needle.Recommended inflation capacities: 3cc balloon: use 5cc sterile water, 5cc balloon: use 10cc sterile water, 30cc balloon: use 35cc sterile water.Do not exceed recommended capacities.Note: aggressive traction, particularly in the presence of suturing, is not recommended for silicone foley catheters.Bard, bardex and lubri-sil are registered trademarks of c.R.Bard, inc.Or an affiliate.U.S.Patent number 5,179,174 and patent pending.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.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.Lubri-sil®, all-silicone, foley catheter peel to open." 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.

Event Description

It was reported that the foley catheter from a lot was inserted and fell off, the patient thought that there was a hole in the balloon, and another lot was inserted and the catheter fell off while during the change in the bed linens.Per follow-up via phone on 14dec2020,the balloons were deflated and tried to fill the fluid into the balloon after they fell off and 5 lots of catheters were having holes in them.The fluid was initially used to inflate the balloon was 10ml in all the first 4 catheters and the 5th one alone filled 5ml into the balloon and the catheter was fell off.

• Brand Name: BARDEX LUBRI-SIL 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: 11093034
• MDR Text Key: 224252586
• Report Number: 1018233-2020-22135
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 175816
• Device Catalogue Number: 175816
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other