MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 2 POP 36MM 30BX; MALE EXTERNAL CATHETER

Model Number	37304
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
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 the male external catheter was too narrow where it connects to the patient tubing; and allows urine to flow back into the catheter.The patients alleged that uti (urinary tract infections) have occurred during the use of the male external catheter.It is unknown at this time if treatment was received for the urinary tract infections.
Additional Manufacturer Narrative
The reported event was unconfirmed.The visual evaluation noted 33 unopened spirit mecs were received.No obvious defects.The samples were tested according to the general inspection level ii/single sampling plan.Eight samples were opened and the funnel inner diameters were measured.The id's measured to be 0.3215", 0.3260", 0.3320", 0.3240", 0.3285", 0.3240", 0.3345", 0.3365", which were found to be within specification (0.33" +/- 0.01").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: "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 wash penis with mild soap and warm water.Dry thoroughly.Trim pubic hair if necessary.Open package at perforation.To remove plastic insert, squeeze catheter at the top of the white cone and pull to release.Unroll self-adhering catheter over penis.Gently squeeze the catheter to properly seal adhesive to the skin.Connect to collection bag.Important: wear time may be significantly reduced if adhesive is not properly sealed to the skin.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.".
Event or Problem Description
It was reported that the male external catheter was too narrow where it connects to the patient tubing; and allows urine to flow back into the catheter.The patients alleged that uti (urinary tract infections) have occurred during the use of the male external catheter.It is unknown at this time if treatment was received for the urinary tract infections.

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 2 POP 36MM 30BX
• Common Device Name: MALE EXTERNAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8429674
• Report Number: 1018233-2019-01388
• Device Sequence Number: 13879177
• Product Code: NNX
• UDI-Device Identifier: 00801741071201
• UDI-Public: (01)00801741071201
• 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: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/28/2023
• Device Model Number: 37304
• Device Catalogue Number: 37304
• Device Lot Number: JUCW0188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 05/12/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 06/03/2019
• 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