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

Model Number	0119L16
Medical Device Problem Codes	Illegible Information (4050); Unclear Information (4052)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
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.Device evaluated by mfr: the device was not returned.
Event or Problem Description
It was reported that the survey respondent stated no, they did not agree that the instructions for use (ifu) for the following bard or becton dickinson products provides sufficient information about the products and their medical applications because of unclear information, missing information, lack of maintenance documentation or guidelines, inadequate instructions for healthcare professional and inadequate or insufficient training in relation to lubricath®, 3-way, 5cc balloon, french size 16.
Event or Problem Description
It was reported that the survey respondent stated no, they did not agree that the instructions for use (ifu) for the following bard or becton dickinson products provides sufficient information about the products and their medical applications because of unclear information, missing information, lack of maintenance documentation or guidelines, inadequate instructions for healthcare professional and inadequate or insufficient training in relation to lubricath®, 3-way, 5cc balloon, french size 16.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr event is not reportable.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® LUBRICATH® 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: 16418046
• Report Number: 1018233-2023-01100
• Device Sequence Number: 14284730
• Product Code: EZC
• UDI-Device Identifier: 00801741019050
• UDI-Public: (01)00801741019050
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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: 0119L16
• Device Catalogue Number: 0119L16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 05/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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