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

Catalog Number	117416
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Inability to Irrigate (1337)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
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 drainage bag itself leaking, reportedly in the seam.Recently they had other two events on temperature sensing foley catheter that do not drain.Two patients recently had temp sensing foleys placed that needed to be removed and replaced shortly after placement.When nursing flushes the catheter nothing comes out of the tip and the drainage hole seems to be faulty.The catheter that customer had was one that needed to be replaced.The patient that came in last night came with a foley from an outside facility that was changed to a temp sensing foley here at 6.45.The patient had no urine output at all and foley was irrigated once with no return, iv lasix was given around 7:30 pm with no output.The foley was replaced around 1 am and the patient has had approximately 100 cc/hr out since then without diuretics.Nursing tried to irrigate the foley that was removed to evaluate what the problem was, and nothing came out of the tip.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation of the returned sample noted one opened (without original packaging), used drain bag, it with spc and tes intact, and red rubber catheter.Visual inspection of the sample noted the catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and allowed to rest with no leaks noted.The balloon passively deflated in under one minute with no issues., the catheter was detached from bag and attempted to flush catheter with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) , and no solution would flow through the catheter drainage funnel, upon further eval the drainage eyes were not punched through.Filled bag with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) through inlet tubing and solution would enter with no issues, no leaks from bag observed.No root cause could be found because the reported event was unconfirmed.A device history record review was not required as the investigation was unconfirmed.As the reported event is unconfirmed a labeling review is not required.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 drainage bag itself leaking, reportedly in the seam.Recently they had other two events on temperature sensing foley catheter that do not drain.Two patients recently had temp sensing foleys placed that needed to be removed and replaced shortly after placement.When nursing flushes the catheter nothing comes out of the tip and the drainage hole seems to be faulty.The catheter that customer had was one that needed to be replaced.The patient that came in last night came with a foley from an outside facility that was changed to a temp sensing foley here at 6.45.The patient had no urine output at all and foley was irrigated once with no return, iv lasix was given around 7:30 pm with no output.The foley was replaced around 1 am and the patient has had approximately 100 cc/hr out since then without diuretics.Nursing tried to irrigate the foley that was removed to evaluate what the problem was, and nothing came out of the tip.Per follow up via phone on (b)(6) 2024,the product was being used on a patient when the defect was noticed.The patient status was unknown.Per follow up via phone on (b)(6) 2024, one sample was sent to bard and used on a patient.

• Brand Name: BARDEX® LUBRICATH® TEMPERATURE-SENSING FOLEY CATHETER
• Common Device Name: 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18520176
• Report Number: 1018233-2024-00128
• Device Sequence Number: 6750864
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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: Lay User/Patient
• Device Catalogue Number: 117416
• Device Lot Number: NGHT2044
• 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: 01/03/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2023
• 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