MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 29MM 30BX

Model Number 35302

Device Problems Nonstandard Device (1420); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.

Event Description

It was reported that the adhesive was too strong on the catheter.The user had a problem with rolling the catheter on.

Manufacturer Narrative

The reported event was confirmed as manufacturer related.4 unopened and 1 opened spirit mecs were returned for evaluation.The samples were visually inspected for holes or damage on the package, legibility of printed numbers and letters, expiration date, correct impression, print color, missing parts of printing, position of printing, damaged component, foreign matter.The samples met the acceptance criteria.The samples were evaluated according to the alleged failure mode: "the adhesive was too strong on the catheter" and 1 of the 5 samples was out of specification.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use 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.".

Event Description

It was reported that the adhesive was too strong on the catheter.The user had a problem with rolling the catheter on.

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 1 STANDARD 29MM 30BX
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7316077
• MDR Text Key: 101843148
• Report Number: 1018233-2018-00699
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741070938
• UDI-Public: (01)00801741070938
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2021
• Device Model Number: 35302
• Device Catalogue Number: 35302
• Device Lot Number: JUAV0263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Date Manufacturer Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1