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

Catalog Number 902814

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 physician in an online survey stated that no, they did not agree 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 illegible information, inaccurate information and missing information in relation to biocath foley catheter preconnected to a 350ml center entry urine meter with 2500ml drainage bag, female length, french size 14.

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.The information provided by bd 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 bd.

Event Description

It was reported that the physician in an online survey stated that no, they did not agree 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 illegible information, inaccurate information and missing information in relation to biocath foley catheter reconnected to a 350ml center entry urine meter with 2500ml drainage bag, female length, french size 14.

• Brand Name: BARD® URINE METER FOLEY TRAY WITH BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: FOLEY TRAY
• 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: 16359856
• MDR Text Key: 309495742
• Report Number: 1018233-2023-00796
• 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,Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 902814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• 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
• Patient Sex: Female