MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 2 POP 32MM 30BX

Model Number 37303

Device Problems Loss of or Failure to Bond (1068); Nonstandard Device (1420)

Patient Problems Pain (1994); Skin Discoloration (2074); 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 patient said the adhesive had ¿gone down¿ which caused the externals to come off at night.He also said they came off in the shower, caused pain, made his skin red and blue, and left adhesive on his skin.Per follow up with the customer on (b)(6) 2020, the adhesive was still stuck on the patient again.It was unknown if he received medical intervention.He tried the 32303 samples and liked them.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿too high viscosity¿ with a potential root cause of ¿viscometer failure or mechanical failure¿.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: "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.

Event Description

It was reported that the patient said the adhesive had ¿gone down¿ which caused the externals to come off at night.He also said they came off in the shower, caused pain, made his skin red and blue, and left adhesive on his skin.Per follow up with the customer on 5feb2020, the adhesive was still stuck on the patient again.It was unknown if he received medical intervention.He tried the 32303 samples and liked them.

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 2 POP 32MM 30BX
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9745370
• MDR Text Key: 184301245
• Report Number: 1018233-2020-01263
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741071195
• UDI-Public: (01)00801741071195
• 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: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 37303
• Device Catalogue Number: 37303
• Device Lot Number: JUDZ0153
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1