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

Catalog Number 175816

Device Problems Inflation Problem (1310); Decrease in Pressure (1490); Device Fell (4014)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 customer stated that the or nurse inserted a urethral foley catheter and inflated the balloon.A few moments later, the catheter fell on the ground.Another urethral foley catheter was inserted, as the physician suggested that the foley balloon be inflated prior to insertion to check the integrity.The or nurse reminded the surgeon that the manufacturer recommended that we discontinue that practice, but complied.The balloon inflated and deflated without issue, so the catheter was inserted.A few moments later, the catheter fell out.After removing the catheter from the ground to the trash, an attempt was made to re-inflate the balloon.However, the water dripped from the catheter and the balloon was not inflated or inflatable.

Event Description

It was reported that the customer stated that the or nurse inserted a urethral foley catheter and inflated the balloon.A few moments later, the catheter fell on the ground.Another urethral foley catheter was inserted, as the physician suggested that the foley balloon be inflated prior to insertion to check the integrity.The or nurse reminded the surgeon that the manufacturer recommended that we discontinue that practice, but complied.The balloon inflated and deflated without issue, so the catheter was inserted.A few moments later, the catheter fell out.After removing the catheter from the ground to the trash, an attempt was made to re-inflate the balloon.However, the water dripped from the catheter and the balloon was not inflated or inflatable.

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿difficult to insert¿.A potential root cause for this failure could be "tortuous anatomy".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: ¿released c.R.Bard, inc.Covington, ga 30014 u.S.A.Made in mexico.Lubricious coating bonded to a bardex® foley catheter made of clear silicone elastomer pk7602585 04/2006.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.H3 other text : the device was not returned.

• 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 GA 30014
• MDR Report Key: 9981777
• MDR Text Key: 188651026
• Report Number: 1018233-2020-02739
• Device Sequence Number: 1
• Product Code: EZL
• 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: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 175816
• Device Lot Number: NGDY2065
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1