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

Model Number 119216M

Device Problems Material Invagination (1336); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2021

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 patient retained urine and not draining even after the foley bag was burped to put air in, and verified there were no kinks or dependent loops.Temperature foley catheter was leaking after insertion and balloon was not fully deflating leaving a lip and ridge.Defect against the lot number was ngfn2786.

Event Description

It was reported that the patient retained urine and not draining even after the foley bag was burped to put air in and verified there were no kinks or dependent loops.Temperature foley catheter was leaking after insertion and balloon was not fully deflating leaving a lip and ridge.Defect against the lot number was ngfn2786.

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.One sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was not used for treatment purposes.The product had caused the reported failure.Visual evaluation of the attached photo sample noted one opened (without original packaging), used temperature sensing silicone foley catheter.Visual inspection of the sample noted balloon mushroom was present upon receipt of the photo.This was out of specification per inspection procedure, which states, "tips to be straight relative to shaft, transition between the shaft and tip must be smooth, ridges, lines, or gouges not permitted, tip must not be malformed, scratched and/or with channels".Furthermore, based on the photo sample attached it is unknown whether inaccurate flow rate or urine leaks occurred because the device could not be tested.A potential root cause for this failure could be incorrect balloon design.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: "sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not resterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use." correction: h.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 actual/suspected device was inspected.

• 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; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11909930
• MDR Text Key: 253526779
• Report Number: 1018233-2021-03141
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046308
• UDI-Public: (01)00801741046308
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 119216M
• Device Catalogue Number: 119216M
• Device Lot Number: NGFN2786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other