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

Model Number 1758SI16

Device Problems Partial Blockage (1065); Inaccurate Flow Rate (1249)

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

Event Date 10/05/2021

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 within the past month or so, the staffs had to replace the foley catheters on at least 6 patients (one three times) because of clotting and other issues directly related to the product not draining.No medical intervention was reported.Per follow-up information received via email on 17-feb-2022, representative asked to confirm the number of foleys that were replaced or affected.And the customer responded that they could not confirm the total number but there were at least 6-7 patients impacted.The problem had continued intermittently, but staff were no longer reporting the issue and just irrigating or changing foleys as needed.There was one particular foley which had only been in 12 hours.The nurse noticed that the output had stopped so they attempted to irrigate but was unsuccessful.When the foley was removed, the clogging was noted at the insertion end.

Manufacturer Narrative

The reported event was confirmed cause unknown.1 sample exhibited the reported failure.The device had not met specifications.The product was used for patient treatment or diagnosis.The product caused the reported failure.Visual evaluation of the photo sample noted one opened (without original packaging), used silicone foley.Visual inspection of the sample noted no that there was an orange coloring within the catheter, which was likely urine.A potential root cause for this failure could be "inadequate material selection".The device history record review could not be performed without a lot number.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 or slip tip syringes 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.3.Using aseptic technique, position the syringe in the center of the sampling port.Press the syringe firmly and twist gently to access the sampling port.4.Slowly aspirate urine sample into syringe and remove syringe from sample port.5.Unkink tubing if necessary 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 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." the actual/suspected device was evaluated.

Event Description

It was reported that within the past month or so, the staffs had to replace the foley catheters on at least 6 patients (one three times) because of clotting and other issues directly related to the product not draining.No medical intervention was reported.Per follow-up information received via email on 17feb2022, representative asked to confirm the number of foleys that were replaced or affected.And the customer responded that they could not confirm the total number but there were at least 6-7 patients impacted.The problem had continued intermittently, but staff were no longer reporting the issue and just irrigating or changing foleys as needed.There was one particular foley which had only been in 12 hours.The nurse noticed that the output had stopped so they attempted to irrigate but was unsuccessful.When the foley was removed, the clogging was noted at the insertion end.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING 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: 13766208
• MDR Text Key: 287829331
• Report Number: 1018233-2022-01305
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741025228
• UDI-Public: (01)00801741025228
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 05/12/2022

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: 1758SI16
• Device Catalogue Number: 119316M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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