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

Catalog Number 36103

Device Problem Nonstandard Device (1420)

Patient Problems Discomfort (2330); Skin Inflammation/ Irritation (4545)

Event Date 07/05/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.

Event Description

It was reported that the glue substance was stuck to application area, causing raw skin and was uncomforting.No medical intervention was reported.Per follow up via phone on (b)(6) 2023, it was reported that patient's prostate was removed two months ago.The batch of male external catheters they received had far too much adhesive to the point where they had to use scissors to gently cut away any residual residue.They used rubbing alcohol as well, but it did little to resolve the issue.

Manufacturer Narrative

Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.

Event Description

It was reported that the glue substance was stuck to application area, causing raw skin and was uncomforting.No medical intervention was reported.As per follow up via phone on (b)(6) 2023, it was reported that patient's prostate was removed two months ago.The batch of male external catheters they received had far too much adhesive to the point where they had to use scissors to gently cut away any residual residue.They used rubbing alcohol as well, but it did little to resolve the issue.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17413706
• MDR Text Key: 319943850
• Report Number: 1018233-2023-05571
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741070990
• UDI-Public: (01)00801741070990
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 36103
• Device Lot Number: JUHR9044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• 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): Other
• Patient Sex: Male