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

Model Number	5323
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "viscometer 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: "fitting the sheath the sheath is a strapless penile sheath: it has an adhesive coating inside to ensure a safe and simple procedure for fitting.If necessary trim pubic hair.Clean and dry pubic area.Remove sheath from its wrapping.Place rolled end over the end of the penis, leaving a small space between the end of the penis and the cup of the sheath.If uncircumcised, do not retract the foreskin but allow it to remain over the glans.Avoid contact between the adhesive and the glans.Slowly unroll the sheath along the shaft of the penis, then gently squeeze the sheath around the penis to ensure even adhesion.Try to avoid leaving a rolled `collar´ of sheath around the base of the penis.Finally, connect the urine collection bag.Always check that the connections are secure before use.Wear time will vary from user to user.It is recommended that a sheath be changed every 24 hours for reasons of hygiene.To remove: the sheath may be removed by gently rolling it o the penis.Avoid simply pulling the sheath o.Removing the sheath whilst having a bath or shower may increase comfort.Do not use on irritated or compromised skin.".
Event or Problem Description
It was reported that the male external catheters were rolling up and causing leaking.Also stated that they were having problems taking the sheaths off as they were so adhesive and were too sticky.The patient stated that this had resulted in bleeding.No medical intervention was reported.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16554295
• Report Number: 1018233-2023-01795
• Device Sequence Number: 14689569
• Product Code: NNX
• UDI-Device Identifier: 00801741071584
• UDI-Public: (01)00801741071584
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2023

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: 10/28/2023
• Device Model Number: 5323
• Device Catalogue Number: 35303
• Device Lot Number: JUCY0024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2018
• 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