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

Catalog Number	119314M
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on friday (b)(6) 2024, a dh nurse placed a 14fr foley catheter on a patient and there was a malfunction of the balloon.The urologist was called in to remove the catheter because the balloon would not inflate and the registered nurse was unable to remove the 2mls of fluid they had put into the balloon.When the urologist came in, they had to use a guide wire to puncture the balloon to inflate it and remove the catheter.Per follow up via email on 10sep2024, it was reported that 14fr foley catheter placed for vcug under sedation was placed in the urethra and the balloon was inflated with 2ml of fluid.The catheter was not able to be pulled back into proper position and the fluid in the balloon was unable to be removed.The team troubleshooted the catheter removal and were unable to remove the catheter.The urologist was called emergently to assist with catheter removal.The catheter port was cut during the troubleshooting process so when the urologist arrived, they placed a sensor wire via the cut balloon port and was able to dislodge fluid from the balloon.At that point, the catheter was removed.The patient was re-prepped and another catheter was placed with some difficulty by the urologist which is documented in the patient record.Ultimately, the patient had a 10fr straight catheter was placed into the bladder.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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 or Problem Description
It was reported that on friday (b)(6)2024, a dh nurse placed a 14fr foley catheter on a patient and there was a malfunction of the balloon.The urologist was called in to remove the catheter because the balloon would not inflate and the registered nurse was unable to remove the 2mls of fluid they had put into the balloon.When the urologist came in, they had to use a guide wire to puncture the balloon to inflate it and remove the catheter.Per follow up via email on 10sep2024, it was reported that 14fr foley catheter placed for vcug under sedation was placed in the urethra and the balloon was inflated with 2ml of fluid.The catheter was not able to be pulled back into proper position and the fluid in the balloon was unable to be removed.The team troubleshooted the catheter removal and were unable to remove the catheter.The urologist was called emergently to assist with catheter removal.The catheter port was cut during the troubleshooting process so when the urologist arrived, they placed a sensor wire via the cut balloon port and was able to dislodge fluid from the balloon.At that point, the catheter was removed.The patient was re-prepped and another catheter was placed with some difficulty by the urologist which is documented in the patient record.Ultimately, the patient had a 10fr straight catheter was placed into the bladder.
Additional Manufacturer Narrative
The reported event was confirmed as cause unknown.No actions can be taken at this time since a root cause was not identified.Received 1 all silicone foley catheter attached to the drainage bag.The returned catheter did not have the inflation valve or cap, it has been cut, therefore no lot number is identified.The sample also had a guide wire entering through the inflation arm and coming out through one of the drainage eyes.The balloon was inspected, and no cuts, pinholes or damages were noted.It was also noted that before this section the guide wire had created a lumen-to-lumen leak, passing to the drainage funnel and coming out through drainage eyelet.The reported event was confirmed.The returned sample does not meet specification which states: catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe.No dhr could be performed as the lot number is unknown.The instructions for use were found adequate and state the following: 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.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.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.Proper techniques for urinary catheter insertion perform hand hygiene immediately before and after insertion insert urinary catheters using aseptic technique and sterile equipment use the smallest foley catheter possible, consistent with good drainage document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in patient record proper techniques for urinary catheter maintenance secure the foley catheter, use the statlock foley stabilization device if provided maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions maintain unobstructed urine flow and keep the catheter and collection tube free from kinking keep the collection bag below the level of the bladder or hips at all times empty the collection bag regularly (e.G., prior to transport) using a separate, clean collection container for each patient routine hygiene (e.G., cleansing of the meatal surface during daily bathing or showering) is appropriate.Leave foley catheter in place only as long as needed.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20266073
• Report Number: 1018233-2024-05851
• Device Sequence Number: 18233716
• Product Code: MJC
• UDI-Device Identifier: 00801741039904
• UDI-Public: (01)00801741039904
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 119314M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 01/11/2025
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 48 KG
• Patient Race: White