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

Catalog Number 36305

Device Problem Biocompatibility (2886)

Patient Problems Urinary Tract Infection (2120); Pressure Sores (2326)

Event Date 11/18/2020

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 had pressure sores from the catheter and recently got over urinary tract infection (uti).It is unknown what medical intervention was provided for the urinary tract infection and pressure sores.

Event Description

It was reported that the patient had pressure sores from the catheter and recently experienced over urinary tract infection (uti).It is unknown what medical intervention was provided for the urinary tract infection and pressure sores.

Manufacturer Narrative

The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to "materials were not biocompatible".It was unknown whether the device had met specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number was unknown, therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "do not use on irritated or compromised skin.Do not use if allergic reaction occurs.Not made with natural rubber latex.".

• 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
• MDR Report Key: 11000152
• MDR Text Key: 221230130
• Report Number: 1018233-2020-21648
• Device Sequence Number: 1
• Product Code: NNX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 36305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other