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

Model Number 165816

Device Problems Difficult to Insert (1316); Material Invagination (1336)

Patient Problems No Consequences Or Impact To Patient (2199); Alteration In Body Temperature (2682)

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 balloon was a raised ribbed area, and the nurses experienced difficulty and were even unable to insert the catheter without resistance.No testing of the balloon was done prior to insertion attempt.

Event Description

It was reported that the balloon was a raised ribbed area, and the nurses experienced difficulty and were even unable to insert the catheter without resistance.No testing of the balloon was done prior to insertion attempt.

Manufacturer Narrative

The reported event was inconclusive due to the poor sample condition.Visual evaluation of the photo sample noted one opened (without original packaging), silicone foley catheter.Visual inspection of the sample noted that the balloon was visible and was extruded beyond the diameter of the shaft.However, without the physical sample available for measurement, it cannot be determined if this deviation is within specification or not.A potential root cause for the reported failure could be, ¿high rtv viscosity.¿ 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: "bard® ez-lok® sampling port (indicated by the blue stem in the port) accepts luer lock (fig.1a) or slip tip syringes (fig.1b).1.Occlude drainage tubing a minimum of 3 inches below the sampling port by kinking the tubing until urine is visible under the access site.2.Swab surface of bard® ez-lok® sampling port with antiseptic wipe.(fig.2) 3.Using aseptic technique, position the syringe in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port (at approximately 80 - 100 degree angle).Press the syringe firmly and twist gently to access the sampling port.(fig.3) 4.Slowly aspirate urine sample into syringe and remove syringe from sample port.(fig.4) 5.Unkink tubing and transfer urine specimen into specimen cup or follow hospital protocol.Discard syringe according to hospital protocol.6.Follow established hospital protocol for specimen labeling and transport to lab.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 re-sterilize.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.".

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9873489
• MDR Text Key: 186701483
• Report Number: 1018233-2020-02061
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Device Lot Number: NGDX1806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1