MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRICATH® FOLEY CATHETER; FOLEY CATHETER (LATEX)

Model Number 0165SI12

Device Problems Inflation Problem (1310); Failure to Infuse (2340); Positioning Problem (3009)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the position of the balloon was different than usual during pretest.Allegedly, the balloon was located on the funnel side.Per additional information received via email on (b)(4) 2019 from ibc representative, the inflation funnel was swollen.

Manufacturer Narrative

The reported event was unconfirmed since the problem could not be reproduced.The evaluation found that the catheter could be inflated without difficulty.The catheter was dissected and found no conditions that could contribute to the reported problem.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: ¿(6) insert catheter into urethral meatus, and advance it until the balloon enters the bladder and urine flows out through the catheter.Using a syringe packaged in the tray, infuse the specified volume of sterile water into the inflation lumen to inflate the balloon." 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 position of the balloon was different than usual during pretest.Allegedly, the balloon was located on the funnel side.Per additional information received via email on 7 february 2019 from ibc representative, the inflation funnel was swollen.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8359225
• MDR Text Key: 137130168
• Report Number: 1018233-2019-00938
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741016738
• UDI-Public: (01)00801741016738
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: 0165SI12
• Device Catalogue Number: 0165L12
• Device Lot Number: 7MY8001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1