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

Model Number	0103L14
Medical Device Problem Codes	Inadequate Instructions for Healthcare Professional (1319); Inaccurate Information (4051)
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.
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 expiration date error, illegible information, inaccurate information, unclear information and inadequate or insufficient training in relation to tiemann model, lubricath®, 2-way, 30cc balloon, french size 14.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr as not reportable.H11: section a through f - the information provided by bard represents all of 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 bard.H3 other text: 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 expiration date error, illegible information, inaccurate information, unclear information and inadequate or insufficient training in relation to tiemann model, lubricath®, 2-way, 30cc balloon, french size 14.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER TIEMANN MODEL COUDE
• 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: 16418514
• Report Number: 1018233-2023-01112
• Device Sequence Number: 3327227
• Product Code: KOD
• UDI-Device Identifier: 00801741018176
• UDI-Public: (01)00801741018176
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K922431
• 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): 04/17/2023

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: 0103L14
• Device Catalogue Number: 0103L14
• 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: 04/18/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 04/27/2023
• 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