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

Catalog Number	36302
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Skin Inflammation/ Irritation (4545); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the 10 male external catheter29mm, medium, rochester, extra adhesive purchased this item and was external condom catheter for urine drainage.After the catheter was inserted into the penis, it took almost 4 hours to remove the product.It was very sticky.No warning or instruction to remove were given on the website which advertised the product.It caused injury to the penis, including bleeding while trying to remove it.Per additional information received via mail on 12dec2024, stated that after inserting the catheter, it remained in place for a duration of 12 hours.When they attempted to remove it, they encountered significant difficulty.The catheter adhered strongly to the skin and found that they could not detach it quickly or easily.In fact, the process of removal took nearly two hours, during which they had to be extremely cautious to avoid causing further discomfort.As they slowly worked to peel it away, they noticed that the adhesive was excessively sticky, leading to irritation of the skin on the penis.Unfortunately, this resulted in injury and subsequent bleeding from the site of injury.It took almost a week for the injury site to heal and topical antibiotics applied to skin over the injured part.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that the 10 male external catheter29mm, medium, rochester, extra adhesive purchased this item and was external condom catheter for urine drainage.After the catheter was inserted into the penis, it took almost 4 hours to remove the product.It was very sticky.No warning or instruction to remove were given on the website which advertised the product.It caused injury to the penis, including bleeding while trying to remove it.Per additional information received via mail on 12dec2024, stated that after inserting the catheter, it remained in place for a duration of 12 hours.When they attempted to remove it, they encountered significant difficulty.The catheter adhered strongly to the skin and found that they could not detach it quickly or easily.In fact, the process of removal took nearly two hours, during which they had to be extremely cautious to avoid causing further discomfort.As they slowly worked to peel it away, they noticed that the adhesive was excessively sticky, leading to irritation of the skin on the penis.Unfortunately, this resulted in injury and subsequent bleeding from the site of injury.It took almost a week for the injury site to heal and topical antibiotics applied to skin over the injured part.
Additional Manufacturer Narrative
The reported event is confirmed - manufacturing related.Visual: received six (6) mecs in closed packaging with no obvious defects.Further testing required.Functional: adhesive peel test was conducted and four (4) samples were tested according to ansi/asqz1.4 c=0 sampling plan, aql- 1.0.Samples were cut to the requirement width 1.00" +/- 0.05" for testing.Samples did not meet test specification range of 1.00-3.60 lbfs.Therefore, product did not meet specifications.Strong adhesive was confirmed.No additional action is required at this time since root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A labeling review is not required because labeling could not have prevented the reported failure.Udi format updated with available product information per gudid.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.

• Brand Name: WIDEBAND¿ SELF-ADHERING MALE EXTERNAL CATHETER
• Common Device Name: 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21036924
• Report Number: 1018233-2024-08421
• Device Sequence Number: 7595412
• Product Code: NNX
• UDI-Device Identifier: 00801741071041
• UDI-Public: (01)00801741071041(11)240624(17)290528(10)JUJS0822
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 36302
• Device Lot Number: JUJS0822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 03/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian