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

Model Number	SW301
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/05/2020
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 condom catheters as a trial indicated on style 3 was almost unremovable.Patient tried at least 10 min in the shower to roll off the condom, with hot soap and water which was very painful with wounds on the penis, also a lot of sticky material remained.Also the style 1 gave the sample problems be it to a slightly lesser extent.
Event or Problem Description
It was reported that condom catheters as a trial indicated on style 3 was almost unremovable.Patient tried at least 10 min in the shower to roll off the condom, with hot soap and water which was very painful with wounds on the penis, also a lot of sticky material remained.Also the style 1 gave the sample problems be it to a slightly lesser extent.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "operator error".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "directions to remove: 1) ensure drainage bag is empty.2) disconnect catheter from the drainage system.3) gently roll the catheter forward and off the penis.If necessary, apply a warm wet compress (such as a wet washcloth) around the catheter to help loosen the adhesive.The baw is attached on the investigation overview element." 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
• Common Device Name: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10748097
• Report Number: 1018233-2020-20513
• Device Sequence Number: 11737200
• Product Code: NNX
• UDI-Device Identifier: 00801741072062
• UDI-Public: (01)00801741072062
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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: SW301
• Device Catalogue Number: 39301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 01/06/2021
• 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