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

Model Number	129416
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
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.Per additional information received on (b)(6) 2023, 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 17 apr 2023, 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.One sample was confirmed to exhibit the reported failure.The used three-way eggshell foley catheter was returned without the original packaging.It was unknown if product was used for patient treatment.Visual evaluation: what appeared to be a pinhole was noted under the balloon on the foley catheter.The catheter balloon was inflated with 10cc di water using a luer lock syringe; the balloon was inflated; water could be seen leaking from the balloon area.After five minutes the balloon was passively deflated; 8.6cc water was returned to the syringe.Microscopic visual observation: the balloon portion was viewed under the microscope at 6x and 20x magnification and a hole/tear was confirmed to present under the balloon, cause the observed leakage.This does not meet specification which states "cap/valve must not leak, and no holes are allowed in the balloon or catheter surface".A potential root cause for this failure mode could be operator did not notice defect/error".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 state the following: "bardex® lubricath® 400-series temperature-sensing foley catheter coude tip 5cc balloon/5ml.Do not restreile.Do not use if package is damaged.Single use.Consult instructions for use.Keep away from sunlight.Contains or presence of natural rubber latex".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.The actual/suspected device was inspected.
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 (b)(6) 2023, customer had returned four each for testing.No medical intervention was reported for any of the patients involved.

• Brand Name: BARDEX® I.C. 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: 16882192
• Report Number: 1018233-2023-03197
• Device Sequence Number: 20698270
• Product Code: MJC
• UDI-Device Identifier: 00801741039799
• UDI-Public: (01)00801741039799
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• 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): 08/28/2023

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 Expiration Date: 04/30/2026
• Device Model Number: 129416
• Device Catalogue Number: 129416
• Device Lot Number: NGFX5338
• 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: 08/29/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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