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

Model Number SW301

Device Problem Nonstandard Device (1420)

Patient Problem No Code Available (3191)

Event Date 10/05/2020

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 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 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.

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
• Type of Device: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10748097
• MDR Text Key: 213447177
• Report Number: 1018233-2020-20513
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741072062
• UDI-Public: (01)00801741072062
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SW301
• Device Catalogue Number: 39301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other