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

Device Problem Biocompatibility (2886)

Patient Problems Urinary Frequency (2275); Hematuria (2558); Dysuria (2684)

Event Date 06/16/2021

Event Type  Injury  

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 patient underwent general anesthesia right transurethral ureteral stenting and right ureteroscopy on (b)(6) 2021.The patient underwent the removal of urinary catheter on the next day after surgery.The patient experienced urinary hematuria appeared when urinating, accompanied by urinary frequency, urgency, and painful urination.The treatment included piperacillin sodium tazobactam anti-infection, kidney protection, stomach protection, rehydration, and other symptomatic supportive treatment.After treatment was provided, the condition improved and hematuria, urinary frequency, urgency, urinary pain disappeared.

Event Description

It was reported that the patient underwent general anesthesia right transurethral ureteral stenting and right ureteroscopy on (b)(6) 2021.The patient underwent the removal of urinary catheter on the next day after surgery.The patient experienced urinary hematuria appeared when urinating, accompanied by urinary frequency, urgency, and painful urination.The treatment included piperacillin sodium tazobactam anti-infection, kidney protection, stomach protection, rehydration, and other symptomatic supportive treatment.After treatment was provided, the condition improved and hematuria, urinary frequency, urgency, urinary pain disappeared.

Manufacturer Narrative

Per additional information received, the customer confirmed the urinary catheter that the patient used did not belong to bard/bd device.Hence, bd has determined that this mdr event is 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.

• 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: 13152700
• MDR Text Key: 283160122
• Report Number: 1018233-2022-00001
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• 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: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Male