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

Catalog Number 907616

Device Problems Inadequate Instructions for Healthcare Professional (1319); Inaccurate Information (4051)

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

Event Date 01/20/2023

Event Type  malfunction  

Event Description

It was reported that the online survey a physician stated that no, user did not agreed that the instructions for use (ifu) for the following bard/becton dickinson product(s) provides sufficient information about the product(s) and its/their medical application(s), because "the ifu presented an expiration date error, inaccurate information, unclear information and inadequate or insufficient training" in relation to biocath® foley catheter preconnected to 2l bardia® bed bag, standard length, french size 16.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

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.

Event Description

It was reported that the online survey a physician stated that no, user did not agreed that the instructions for use (ifu) for the following bard/becton dickinson product(s) provides sufficient information about the product(s) and its/their medical application(s), because "the ifu presented an expiration date error, inaccurate information , unclear information and inadequate or insufficient training " in relation to biocath® foley catheter preconnected to 2l bardia® bed bag, standard length, french size 16.

• Brand Name: BARD® FOLEY CATHETER TRAY WITH 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: 16328069
• MDR Text Key: 309130028
• Report Number: 1018233-2023-00730
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2023

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: Health Professional
• Device Catalogue Number: 907616
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2023
• 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