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

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Skin Tears (2516); Urethral Stenosis/Stricture (4501)

Event Date 01/05/2023

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 customer had a transurethral resection of the prostate (turp) surgery, and the design of the catheter was causing them issues.The customer did not give medical intervention information.The date of the event was january 5th.Per follow-up information received on 22feb2023, stated that the customer was using a 3-way foley and had a spontaneous erection.During the erection, the customer had a tear to their urethra.The customer developed a stricture and was having a procedure to rectify it.They suggested that 2¿3 inches need to be added to the catheter to prevent this issue.

Manufacturer Narrative

The reported event is inconclusive as no sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.A potential root cause for this failure mode could be due to incorrect former selection caused incorrect catheter size dipped.The dhr review could not be performed without a lot number.Unable to review the labelling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.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.

Event Description

It was reported that the customer had a transurethral resection of the prostate (turp) surgery and the design of the catheter was causing them issues.The customer did not give medical intervention information.The date of event was january 5th.Per follow-up information received on (b)(6) 2023, stated that the customer was using a 3 way foley and had a spontaneous erection.During the erection, the customer had a tear to their urethra.The customer developed a stricture and was having a procedure to rectify it.They suggested that 2-3 inches need to be added to the catheter to prevent this issue.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16543893
• MDR Text Key: 311289858
• Report Number: 1018233-2023-01728
• 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,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• 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: 03/30/2023
• 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): Required Intervention