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

Model Number	35303
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
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 device was not returned.
Event or Problem Description
It was reported that one of the male external catheters were incorrectly packaged and the adhesive was on the packaging.Also stated that there was no direction for the items.The complainant stated that one catheter of 32 mm was remaining, and they would try it.The representative sent a link for an instruction video on male external catheters.It was noted that the patient had been using the product for less than 90 days.
Event or Problem Description
It was reported that one of the male external catheters were incorrectly packaged and the adhesive was on the packaging.Also stated that there was no direction for the items.The complainant stated that one catheter of 32 mm was remaining, and they would try it.The representative sent a link for an instruction video on male external catheters.It was noted that the patient had been using the product for less than 90 days.Per customer contact via phone on 11nov2021, it was stated that there were no directions on how to use the male external catheters and there was no measurement tool.As a new user, they needed this and it was later stated that they were offered a link to a video that explained things.Per follow-up via phone on 17nov2021 , customer stated about the sizing guide used for measuring the penis when ordering condom catheters but patient did not have a sizing guide.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "placement omission".It was unknown whether the device had met specifications.Based on patient code 2645 the product does not appear to have been used.However, the product is intended to be used for treatment purpose but it is unknown whether the product had a relationship with the reported event.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labeling could not have prevented the reported failure.The device was not returned.

• 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
• 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: 12624484
• Report Number: 1018233-2021-06365
• Device Sequence Number: 17211193
• Product Code: NNX
• UDI-Device Identifier: 00801741070945
• UDI-Public: (01)00801741070945
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• 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: Lay User/Patient
• Device Model Number: 35303
• Device Catalogue Number: 35303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown