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

Model Number	39303
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
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 stated that there was too much adhesive near the tip and the inside of the male external catheter which was sticking together and not draining.
Additional Manufacturer Narrative
The reported event was unconfirmed as the product meets the specifications.Visual evaluation noted one unopened male external catheter (mec) was received.No obvious defects were noted.It was determined that the adhesive peel strength was found to be within the specifications.A potential root cause for this failure mode was unable to determine due to the reported issue was unconfirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Per investigation a labeling review was not required.The actual/suspected device was inspected.
Event or Problem Description
It was reported by the patient that there was too much adhesive near the tip and inside the male external catheter which was sticking together and not draining.

• Brand Name: SPIRIT HYDROCOLLOID ADHESIVE SHEATH
• Common Device Name: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11569217
• Report Number: 1018233-2021-01585
• Device Sequence Number: 14504561
• Product Code: NNX
• UDI-Device Identifier: 00801741071348
• UDI-Public: (01)00801741071348
• 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
• Report Date (Section B): 08/02/2021

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: 39303
• Device Catalogue Number: 39303
• Device Lot Number: JUEX0297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 08/25/2021
• 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