MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AURORA HYDROCOLLOIDE ADHESIVE SHEATH; MALE EXTERNAL CATHETER

Model Number	SP301
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
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.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 adhesive layer of the male external catheter did not stick properly, and nurse stated that there were air bubbles in the adhesive layer.Per additional information received via ibc on 18oct2021, it was reported that the adhesive layer of the male external catheter had full of air bubbles and there was too little plaque in the inner wall, hence customer was not able to unroll it.So, it seemed as whether there was too little sticky material on the inside.And also, user stated that edge of male external catheters were rolled off and it strongly stuck to the fingers.As per follow up information received on 21oct2021, it seems that there was less adhesive on the inside of the condom catheter, making them stick less well and there was no impact to the patient(s) due to use of these devices and several sheaths but not all of them.But too much to ignore the problem.
Event or Problem Description
It was reported that the adhesive layer of the male external catheter did not stick properly, and nurse stated that there were air bubbles in the adhesive layer.Per additional information received via ibc on 18oct2021, it was reported that the adhesive layer of the male external catheter had full of air bubbles and there was too little plaque in the inner wall, hence customer was not able to unroll it.So, it seemed as whether there was too little sticky material on the inside.And also, user stated that edge of male external catheters were rolled off and it strongly stuck to the fingers.As per follow up information received on 21oct2021, it seems that there was less adhesive on the inside of the condom catheter, making them stick less well and there was no impact to the patient(s) due to use of these devices and several sheaths but not all of them.But too much to ignore the problem.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be "operator error".It was unknown whether the device had met specifications.The product was used for treatment, but it was unknown whether the product had caused the reported failure.The device was not returned for evaluation.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: ¿intended use: the self-adhering male external catheter is used for the drainage of urine.The catheter is applied by the patient or caregiver.Description / indication: the self-adhering male external catheter is designed for the management of adult male urinary incontinence.Contraindication: do not use on irritated or compromised skin.Warning: reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury or illness of the patient.Precaution: 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.¿ h11: section a through f - the information provided by bd 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 bd.

• Brand Name: AURORA HYDROCOLLOIDE ADHESIVE SHEATH
• 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 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12780193
• Report Number: 1018233-2021-07075
• Device Sequence Number: 3459451
• Product Code: NNX
• UDI-Device Identifier: 00801741071966
• UDI-Public: (01)00801741071966
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/28/2025
• Device Model Number: SP301
• Device Catalogue Number: SP301
• Device Lot Number: JUEZ0740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2021
• 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: Other
• Patient Sex: Male