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

Model Number	39302
Medical Device Problem Codes	Nonstandard Device (1420); Device Handling Problem (3265)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the male external catheter stuck to patient and experienced hurt.It was further reported that the patient was missing the tube in it.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed as a use related.A potential root cause for this failure mode could be due to the user uses the catheter for multiple days.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device history record review was not required due to the reported issue was confirmed as use related.The instructions for use were found adequate and state the following: "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.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.Important: wear time may be reduced if adhesive is not properly sealed to the skin.¿ 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 or Problem Description
It was reported that the male external catheter stuck to the patient and experienced pain.It was further reported that the patient was missing the tube in it.No medical intervention was reported.Per customer via phone on (b)(6) 2021 the customer received a replacement tube for the missing leg bag tube.The customer had a male external that stuck to the skin and hurt while removing.The patient learned that wearing them long enough allowed the adhesive to be less strong over the time.And also stated that the customer switched to non adhesive male external catheter (38304) but it would not stay in place.The customer had 29 unused male external catheters to return.The customer had a leg bag that retained urine odor even after cleaning.Per customer via phone on (b)(6) 2021 the product (32304) was worn about a week or two before removing and still leave sticky residue on the penis which was difficult to remove.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d.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 or Problem Description
It was reported that the male external catheter stuck to patient and experienced hurt.It was further reported that the patient was missing the tube in it.No medical intervention was reported.

• Brand Name: POP-ON 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
• MDR Report Key: 11999678
• Report Number: 1018233-2021-03516
• Device Sequence Number: 19730134
• Product Code: NNX
• UDI-Device Identifier: 00801741071331
• UDI-Public: (01)00801741071331
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/28/2025
• Device Model Number: 39302
• Device Catalogue Number: 32304
• Device Lot Number: JUEW2207
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 06/25/2021; 08/31/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 07/20/2021; 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other