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

Catalog Number 175810

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems Pain (1994); Sedation (2368)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.

Event Description

It was reported that the clinician was unable to remove the catheter from the patient.The catheter was initially inserted in the patient post-surgery in the operating room.The clinician attempted to remove the catheter in the ward a few days later, as per protocol.The clinician deflated the catheter balloon using a syringe, but the balloon would not completely deflate.The clinician attempted to remove the catheter by force, and the patient allegedly experienced pain.The patient required hospital admission for removal of the catheter under sedation.The catheter was cut and removed by force.Per additional information received via email on 7 september 2018 from helen fierro (complainant), it was unknown what medication was administered to the patient.

Manufacturer Narrative

The reported event was inconclusive due to a poor sample condition.Visual evaluation of the returned sample noted one opened, used catheter with the entire funnel and inflation arm cut off and missing.The drainage lumen was flushed.Since there was no inflation arm or valve remaining, no functional testing of inflation or deflation could be done.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone.English warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Units this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.¿ use luer tip syringe to inflate with stated ml of sterile water.Or ¿ for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.For urological use only.Do not use if package is damaged.Bard, bardex, bardia, biocath and lubricath are trademarks and/or registered trademarks of c.R.Bard, inc.Single use only.Do not resterilize consult instructions for use.C.R.Bard, inc.Covington, ga 30014 usa 1 800 526 4455 www.Bardmedical.Com manufacturer: 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 necessary, 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." patient code: (b)(4).

Event Description

It was reported that the clinician was unable to remove the catheter from the patient.The catheter was initially inserted in the patient post-surgery in the operating room.The clinician attempted to remove the catheter in the ward a few days later, as per protocol.The clinician deflated the catheter balloon using a syringe, but the balloon would not completely deflate.The clinician attempted to remove the catheter by force, and the patient allegedly experienced pain.The patient required hospital admission for removal of the catheter under sedation.The catheter was cut and removed by force.Per additional information received via email on (b)(6)2018 from helen fierro (complainant), it was unknown what medication was administered to the patient.

• 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: 7917091
• MDR Text Key: 121991706
• Report Number: 1018233-2018-04468
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K984084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 175810
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Manufacturer Received: 09/03/2018
• Initial Date FDA Received: 09/27/2018
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention