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

Model Number 119314

Device Problems Inaccurate Flow Rate (1249); No Flow (2991)

Patient Problems Urinary Retention (2119); No Known Impact Or Consequence To Patient (2692)

Event Date 08/17/2018

Event Type  malfunction  

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 on the day of placement, it was difficult for urine to flow from the catheter.The device was replaced, and the user confirmed that 500 cc of urine flowed.

Manufacturer Narrative

The reported event was unconfirmed.Visual evaluation noted one used silicone catheter and drainage bag with no original packaging present.Catheter balloon was inflated with 10ml of a methylene blue and water solution.No resistance to balloon inflation was observed.No lumen to lumen leakage was observed, and no leaks along the shaft or around the catheter balloon were observed.Flushed the drainage lumen from the drain eyes into the drainage bag.Flushed the drainage lumen from the funnel side towards the drainage eyes.Solution flowed unobstructed through the drainage lumen.Volume of the drainage and time was not measured as the sample was returned used (specification states catheter must drain).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: ¿visually inspect the product for any imperfections or surface deterioration prior to use.Note: compatible only with the bard criticore monitor, bard urotrack 224 monitor, and other 400-series temperature monitors.Interchangeability + 0.2oc at 37oc.".

Event Description

It was reported that on the day of placement, it was difficult for urine to flow from the catheter.The device was replaced, and the user confirmed that 500 cc of urine flowed.

• Brand Name: BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7864708
• MDR Text Key: 120107127
• Report Number: 1018233-2018-04110
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039843
• UDI-Public: (01)00801741039843
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2023
• Device Model Number: 119314
• Device Catalogue Number: 119314
• Device Lot Number: NGBZ0527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1