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

Model Number 36101

Device Problem Nonstandard Device (1420)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/10/2022

Event Type  malfunction  

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 experiencing an adhesiveness issue with the male external catheter.This issue has occurred multiple times and caused bleeding.Additionally, the customer thought the last replacements they received may have been expired and contributed to this issue.

Manufacturer Narrative

The reported event is confirmed- manufacturing related.Visual evaluation noted received 4 mec in original packaging.Adhesiveness was found during sample preparation as sample was sticking to surfaces.Pictures attached in investigation overview elements to show adhesiveness present with mec.Therefore, product does not meet specification.A review of the device history review did not show any problems or conditions that could have contributed to the reported event.Based on the results of this investigation no additional actions are required at this time.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: "description/indication: the self-adhering male external catheter is designed for the management of male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Precaution: do not use if allergic reaction occurs.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Directions: to apply: 1) wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) open package at perforation.4) to remove plastic insert, squeeze catheter at the top of the white cone and pull to release.5) unroll self-adhering catheter over penis.6) gently squeeze the catheter to properly seal adhesive to the skin.7) connect to collection bag.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.Directions: to remove gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive." 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 actual/suspected device was inspected.

Event Description

It was reported that the customer experiencing an adhesiveness issue with the male external catheter.This issue has occurred multiple times and caused bleeding.Additionally, the customer thought the last replacements they received may have been expired and contributed to this issue.Per additional information received via email on 15apr2022, customer returned additional male external catheter from different lot.

Manufacturer Narrative

The reported event is inconclusive as the evaluated representative samples failed the adhesive peel test.Although an exact root cause could not be determined a potential root cause could be mechanical failure.A review of the dhr did not show any problems or conditions that would have contributed to the reported event.Based on the results of the investigation no additional actions are required at this time.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: "description/indication the self-adhering male external catheter is designed for the management of male urinary incontinence.Contraindication do not use on irritated or compromised skin.Precaution do not use if allergic reaction occurs.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Directions: to apply 1) wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) open package at perforation.4) to remove plastic insert, squeeze catheter at the top of the white cone and pull to release.5) unroll self-adhering catheter over penis.6) gently squeeze the catheter to properly seal adhesive to the skin.7) connect to collection bag.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.Directions: to remove gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive." 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 actual/suspected device was inspected.

Event Description

It was reported that the customer experiencing an adhesiveness issue with the male external catheter.This issue has occurred multiple times and caused bleeding.Additionally, the customer thought the last replacements they received may have been expired and contributed to this issue.Per additional information received via email on 15apr2022, customer returned additional male external catheter from different lot.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13694178
• MDR Text Key: 286770749
• Report Number: 1018233-2022-01136
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741070976
• UDI-Public: (01)00801741070976
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 36101
• Device Catalogue Number: 36101
• Device Lot Number: JUEZ1049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2022
• Initial Date FDA Received: 03/08/2022
• Supplement Dates Manufacturer Received: 06/15/2022; 10/11/2022
• Supplement Dates FDA Received: 07/05/2022; 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• 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