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

Model Number 0119L20

Device Problems Incorrect Measurement (1383); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the survey respondent stated no and they did not agree that they were able to successfully place the foley catheter in a patient because needed to change the foley size in relation to lubricath, 3-way, 5cc balloon, french size 20.

Event Description

It was reported that the survey respondent stated no and they did not agree that they were able to successfully place the foley catheter in a patient because needed to change the foley size in relation to lubricath, 3-way, 5cc balloon, french size 20.

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
• Type of Device: 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: 16318495
• MDR Text Key: 309145884
• Report Number: 1018233-2023-00682
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741019074
• UDI-Public: (01)00801741019074
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0119L20
• Device Catalogue Number: 0119L20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other