MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 WIDEBAND¿ SELF-ADHERING MALE EXTERNAL CATHETER

Model Number 36302

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Date 03/01/2022

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 experienced two urinary tract infections back-to-back.The first urinary tract infection occurred in january.The infection later reappeared, however the patient is now using a different antibiotic.The patient noted that it may be the male external catheter.It was also not that catheter crinkled and the adhesive did not hold up well and a pool of urine formed which may have caused the urinary tract infection.It is unknown if the device contributed to the urinary tract infections at this time and medical intervention is unknown.

Event Description

It was reported that the patient experienced two urinary tract infections back-to-back.The first urinary tract infection occurred in january.The infection later reappeared, however the patient is now using a different antibiotic.The patient noted that it may be the male external catheter.It was also not that catheter crinkled and the adhesive did not hold up well and a pool of urine formed which may have caused the urinary tract infection.It is unknown if the device contributed to the urinary tract infections at this time and medical intervention is unknown.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿materials not biocompatible¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿intended use: the self-adhering male external catheter is used for the drainage of urine.The catheter is applied by the patient or caregiver.Description / indication: the self-adhering male external catheter is designed for the management of adult male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Warning: reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury or illness of the patient.Precaution: do not use if allergic reaction occurs or if patient has known allergies to device components.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Follow directions to remove if experiencing swelling, numbness, discomfort, pain, discoloration, or abnormal appearance.Note: if experiencing problems with use of the device, please consult your healthcare professional for assistance.Directions to apply: 1) verify correct size prior to use.2) trim pubic hair if necessary.3) wash penis with mild soap and warm water.Dry thoroughly.Wear time may be reduced if skin is not dry or cream/oil is used.4) open package at perforation.Remove catheter from plastic insert, if present.5) place rolled end over the end of the penis, leaving a small space between the end of the penis and the cone of the catheter.6) unroll the catheter over penis.7) gently squeeze the catheter to properly seal adhesive to the skin.If possible, avoid leaving a rolled ¿collar¿ around the base of the penis.Important: wear time may be reduced if adhesive is not properly sealed to the skin.8) connect the catheter to a drainage system.Make sure to check that connections are secure before use.Directions to remove: 1) ensure drainage bag is empty.2) disconnect catheter from the drainage system.3) gently roll the catheter forward and off the penis.If necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive.Disposal: after removal, dispose by placing the used catheter into a waste container.¿ the device was not returned.

• Brand Name: WIDEBAND¿ SELF-ADHERING MALE EXTERNAL CATHETER
• Type of Device: MALE EXTERNAL 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: 13903892
• MDR Text Key: 287913257
• Report Number: 1018233-2022-01598
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741071041
• UDI-Public: (01)00801741071041
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 36302
• Device Catalogue Number: 36302
• Device Lot Number: JUFW9123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2021
• 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: Male