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

Device Problem Shipping Damage or Problem (1570)

Patient Problem Urinary Tract Infection (2120)

Event Date 11/01/2021

Event Type  Injury  

Event Description

It was reported that the flip-flop valve caused infections because it was too difficult to clean.Per follow-up via phone on (b)(6) 2021, the patient had to use the catheter longer than they should because they were out of supply.It was stated that the liberator was unable to send the ones, they needed timely.It was also stated that liberator did not send the correct catheter that the patient required.The patient wanted an infection control catheter because of urinary tract infection with use of these catheters because there was no infection control coating on them.The patient had prescribed antibiotics for the urinary tract infection.

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 flip-flop valve caused infections because it was too difficult to clean.Per follow-up via phone on (b)(6) 2021, the patient had to use the catheter longer than they should because they were out of supply.It was stated that the liberator was unable to send the ones, they needed timely.It was also stated that liberator did not send the correct catheter that the patient required.The patient wanted an infection control catheter because of urinary tract infection with use of these catheters because there was no infection control coating on them.The patient had prescribed antibiotics for the urinary tract infection.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.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.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: LATEX 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12872592
• MDR Text Key: 281544849
• Report Number: 1018233-2021-07534
• Device Sequence Number: 1
• Product Code: EZC
• 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,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• 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): Required Intervention