MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CLEAR ADVANTAGE MALE CONTINENCE SHEATH; MALE EXTERNAL CATHETER

Model Number	786225
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
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 patient used the male external catheter for a while and there had been no issues until that box.The patient stated the sheaths were not sticky and had a powdery feel.It was reported that upon sample investigation, a strong adhesive result was found for the male external catheter.
Additional Manufacturer Narrative
The reported event is confirmed - cause unknown.Visual evaluation noted 6 unopened mecs were received.No obvious defects were noted.Further testing required.Adhesive peel test was performed per tm0301209 revision 2.Samples were tested according to ansi/asq z1.4-2003 (r2013), aql- 1.0, general inspection level ii.Samples were cut to the required width (1.00" +/- 0.05").Adhesive peel strength was found to be high out of specification (1.14 lbs.- 3.04 lbf).Although an exact root cause could not be determined, a potential root cause is mechanical failure.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labeling could not have prevented the reported failure.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 actual/suspected device was inspected.
Event or Problem Description
It was reported that the patient used the male external catheter for a while and there had been no issues until that box.The patient stated the sheaths were not sticky and had a powdery feel.It was reported that upon sample investigation, a strong adhesive result was found for the male external catheter.

• Brand Name: CLEAR ADVANTAGE MALE CONTINENCE 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: 12706227
• Report Number: 1018233-2021-06707
• Device Sequence Number: 4614467
• Product Code: NNX
• UDI-Device Identifier: 00801741071720
• UDI-Public: (01)00801741071720
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/11/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2025
• Device Model Number: 786225
• Device Catalogue Number: 786225
• Device Lot Number: JUFN2556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2021
• 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