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

Catalog Number 119216M

Device Problem Insufficient Information (3190)

Patient Problems Urinary Retention (2119); Discomfort (2330); Palpitations (2467); Abdominal Distention (2601)

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 patient experienced bladder discomfort, urine retention, bladder distention and bladder palpitations.

Event Description

It was reported that the patient experienced bladder discomfort, urine retention, bladder distention and bladder palpitations.

Manufacturer Narrative

The reported issue was unconfirmed.Per visual inspection no defects were found along of the catheter.Per functional evaluation, the catheter balloon was inflated with air and water and no defects were found.The device was then injected with water by way of the drainage lumen and no leakage was found.Per dimensional evaluation the catheter was found within specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "sterile: unless package is opened or damaged.Do not resterilize.For urological use only.Recommended inflation capacities 8 fr.And 10 fr.(3cc balloon): use 3.5cc sterile water 12 fr.(5cc balloon): use 5.5cc sterile water 14 fr.And larger (5cc balloon): use 10cc sterile water do not exceed recommended capacities.Visually inspect the product for any imperfections or surface deterioration prior to use." (b)(4).

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; lot 57c; covington GA 30014
• MDR Report Key: 6699668
• MDR Text Key: 79572214
• Report Number: 1018233-2017-03585
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/19/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2021
• Device Catalogue Number: 119216M
• Device Lot Number: NGAT1291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 07/10/2017
• Supplement Dates Manufacturer Received: 02/14/2018
• Supplement Dates FDA Received: 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other