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

Model Number A902416

Device Problems Inadequate Instructions for Healthcare Professional (1319); Material Invagination (1336)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2022

Event Type  malfunction  

Event Description

It was reported that the temperature-sensing foley catheter was removed from the patient who complained of discomfort and cuffing was observed on the photo sample, which caused discomfort during removal.It was also stated that 2 of the patients experienced discomfort.As per additional information received via email on 21oct2022, customer stated that they still continued to see riskonnect entered that their patients were reporting painful removal of the foley, and a ring was identified at the tip of the catheter on removal.No medical intervention was reported.As per additional information received via email on 01nov2022, stated that there was a ring around the tip which was trauma or bleeding or pain to patients upon removal.They had 2 riskconnects placed on (b)(6) 2022 previously for 2 intensive care unit patients.Stated that there was another report of a patient at the time, but this was not entered in riskconnect.There were then 2 new riskconnect entered that morning for 2 spine patients for (b)(6) 2022 with the same event.All patients had a procedure that event in the operating room and it was believed that those foley were placed intra-op.The foley was sequestered that morning and the lot number read lot# ngfy4396 and interestingly enough when they opened the new foley that day and compared the lot number from the outside of the box and what the foley said lot# ngfx4867 both had different lot numbers.

Manufacturer Narrative

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

Manufacturer Narrative

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

It was reported that the temperature-sensing foley catheter was removed from the patient who complained of discomfort and cuffing was observed on the photo sample, which caused discomfort during removal.It was also stated that 2 of the patients experienced discomfort.As per additional information received via email on (b)(6) 2022, customer stated that they still continued to see riskonnect entered that their patients were reporting painful removal of the foley, and a ring was identified at the tip of the catheter on removal.No medical intervention was reported.As per additional information received via email on (b)(6) 2022, stated that there was a ring around the tip which was trauma or bleeding or pain to patients upon removal.They had 2 riskconnects placed on (b)(6) previously for 2 intensive care unit patients.Stated that there was another report of a patient at thet time, but this was not entered in riskconnect.There were then 2 new riskconnect entered that morning for 2 spine patients for (b)(6) 2022 with the same event.All patients had a procedure that event in the operating room and it was believed that those foley were placed intra-op.The foley was sequestered that morning and the lot number read lot# ngfy4396 and interestingly enough when they opened the new foley that day and compared the lot number from the outside of the box and what the foley said lot# ngfx4867 both had different lot numbers.

Event Description

It was reported that the temperature-sensing foley catheter was removed from the patient who complained of discomfort and cuffing was observed on the photo sample, which caused discomfort during removal.It was also stated that 2 of the patients experienced discomfort.As per additional information received via email on (b)(6) 2022, customer stated that they still continued to see riskonnect entered that their patients were reporting painful removal of the foley and a ring was identified at the tip of the catheter on removal.No medical intervention was reported.As per additional information received via email on (b)(6) 2022, stated that there was a ring around the tip which was causing trauma, bleeding, and pain to patients upon removal.They had 2 riskonnects placed on (b)(6) 2022 and on (b)(6) 2022 previously for 2 intensive care unit patients.Stated that there was another report of a coi patient at that time, but this was not entered in riskonnect.There were then 2 new riskonnect entered that morning for 2 spine patients for (b)(6) 2022 with the same event.All patients had a procedure preceding that event in the operating room and it was believed that those foley were placed intra-op.The foley was sequestered that morning and the lot number read lot# ngfy4396 and when they opened the new foley that day and compared the lot number from the outside of the box and what the foley said lot# ngfx4867 both had different lot numbers.The outside of the box showed ngfx4867 and inside foley had a lot number of ngy4396.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "inadequate material selection".It was unknown whether the device had met relevant specifications.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and states the following: "sterile: unless package is opened or damaged.Warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single use only.Do not reuse.Do not re-sterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 30cc balloon: use 35ml sterile water do not exceed recommended capacities.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use." correction- b, g 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.H3 other text : the device was not returned.

• Brand Name: BARDEX® ALL-SILICONE 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15788476
• MDR Text Key: 307590035
• Report Number: 1018233-2022-08734
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2023

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: A902416
• Device Catalogue Number: 165816
• Device Lot Number: NGFY4396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 11/01/2022; 02/15/2023
• Supplement Dates FDA Received: 11/22/2022; 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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