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

Model Number	117416
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer had encountered issue with the balloons of silicone indwelling catheters losing fluid and deflating earlier this week.The foley catheter was placed on (b)(6) 2023 in surgery, and it was documented that the balloon was inflated.However, at the time of catheter removal, the balloon was found to be completely deflated (lot# nggr3688).This was the first time they had heard of this issue, but the registered nurse on this patient care unit noted this multiple times recently (lot# unk).Although they did not have any specifics or the catheter.They did re-inflate the balloon yesterday and placed it in a bag to save it.Today, there was some fluid in the bag, which would indicate the balloon was slowly leaking.Per additional information received on 15apr2023, it was reported that the customer were showing that they had a total of four different foleys in their office waiting that they can return for investigation.The 3 catheters that seem to have an issue with deflating balloons, one foley had slipped out of the patient, and nurse stated that they tested the balloon and felt a leak (lot# ngfx5338) other foley (lot# nggx0360) and an other foley (lot# ngg20749).Per follow up via phone 17apr2023, customer had returned four each for testing.No medical intervention was reported for any of the patients involved.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 the customer had encountered issue with the balloons of silicone indwelling catheters losing fluid and deflating earlier this week.The foley catheter was placed on (b)(6) 2023 in surgery, and it was documented that the balloon was inflated.However, at the time of catheter removal, the balloon was found to be completely deflated (lot# nggr3688).This was the first time they had heard of this issue, but the registered nurse on this patient care unit noted this multiple times recently (lot# unk).Although they did not have any specifics or the catheter.They did re-inflate the balloon yesterday and placed it in a bag to save it.Today, there was some fluid in the bag, which would indicate the balloon was slowly leaking.As per additional information received on 15apr2023, it was reported that the customer were showing that they had a total of four different foleys in their office waiting that they can return for investigation.The 3 catheters that seem to have an issue with deflating balloons, one foley had slipped out of the patient, and nurse stated that they tested the balloon and felt a leak (lot# ngfx5338) other foley (lot# nggx0360) and an other foley (lot# ngg20749) as per follow up via phone 17apr2023, customer had returned four each for testing.No medical intervention was reported for any of the patients involved.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.A potential root cause for this failure mode could be, ¿rough handling (operator error)¿.The device had not met specifications.Visual evaluation noted a pinhole on catheter below the inflation cap.The catheter balloon was inflated with 10cc di water using a luer lock syringe; when the catheter was being inflated, the water could be seen slowly leaking from the pinhole.The catheter did not inflate concentrically as a result of the water leaking from the pinhole during inflation.After 5 minutes, the balloon was passively deflated and 9.4cc was returned to the syringe.Microscopic visual evaluation: the catheter was viewed under the microscope at 15x magnification, and a hole was confirmed to be present beneath the inflation cap.This does not meet the specification "cap and valve must be present and assembled.The tip of the black material of the valve must be visible on the surface of the cap [3] without cuts, holes or tears on the inflation arm.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A labeling review was not performed because labelling could not have prevented the reported failure.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® LUBRICATH® TEMPERATURE-SENSING FOLEY CATHETER
• Common Device Name: 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: 16875539
• Report Number: 1018233-2023-03168
• Device Sequence Number: 12585597
• Product Code: EZC
• UDI-Device Identifier: 00801741076930
• UDI-Public: (01)00801741076930
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K913341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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
• Operator of Device: Health Professional
• Device Model Number: 117416
• Device Catalogue Number: 117416
• Device Lot Number: NGGX0360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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: Other
• Patient Sex: Unknown