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

Model Number 35303

Device Problems Nonstandard Device (1420); Difficult to Remove (1528); Material Deformation (2976)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

It was reported that the cunningham clamp should be more circular as it caused pain to the patient and the external catheters were hard to remove.

Event Description

It was reported that the cunningham clamp should be more circular as it caused pain to the patient and the external catheters were hard to remove.

Manufacturer Narrative

The reported event was inconclusive.It was unknown whether the device had met specifications due to no sample was returned for evaluation.The product was used for treatment purposes.A potential failure mode could be ¿too high viscosity¿ with a potential root cause of ¿viscometer failure or mechanical failure¿.This failure falls in a quad 2 risk region and based on this information the risk is moderate.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "description/indication the self-adhering male external catheter is designed for the management of male urinary incontinence.Contraindication do not use on irritated or compromised skin.Precaution do not use if allergic reaction occurs.For good hygiene, change catheter daily.Use of a single device for longer periods than 24 hours may increase the risk of complications.Directions: to apply 1) wash penis with mild soap and warm water.Dry thoroughly.2) trim pubic hair if necessary.3) unroll self-adhering catheter over penis.4) gently squeeze the catheter to properly seal adhesive to the skin.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.5) connect to drainage device.Directions: to remove gently roll catheter off the penis.Note: if necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive." 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.H3 other text : the device was not returned.

• Brand Name: SPIRIT HYDROCOLLOID ADHESIVE SHEATH
• Type of Device: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10093748
• MDR Text Key: 193044249
• Report Number: 1018233-2020-03464
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741070945
• UDI-Public: (01)00801741070945
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 35303
• Device Catalogue Number: 35303
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1