MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC WIDEBAND L 100BX

Model Number 36104

Device Problems Nonstandard Device (1420); Output above Specifications (1432)

Patient Problems No Patient Involvement (2645); 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

During the evaluation of the lot samples received for a separate complaint, one of the samples was found to be above the specification for peel strength.Therefore, this complaint was entered to capture the malfunction of the sample.

Event Description

It was reported during the evaluation of the lot samples received for a separate complaint, one of the samples was found to be above the specification for peel strength.Therefore, this complaint was entered to capture the malfunction of the sample.

Manufacturer Narrative

The reported event was confirmed as manufacturer related.Per visual inspection, no damages were noted in the sample.The sample was evaluated according to the alleged failure mode: "strong adhesive".The evaluation was performed and the tested sample was found above the specification 0.80lb-2.80lb.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: "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) open package at perforation.4) to remove plastic insert, squeeze catheter at the top of the white cone and pull to release.5) unroll self-adhering catheter over penis.6) gently squeeze the catheter to properly seal adhesive to the skin.7) 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.".

• Brand Name: ROCHESTER MEC WIDEBAND L 100BX
• Type of Device: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7365051
• MDR Text Key: 103526568
• Report Number: 1018233-2018-00920
• Device Sequence Number: 1
• Product Code: NNX
• UDI-Device Identifier: 00801741071003
• UDI-Public: (01)00801741071003
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/28/2021
• Device Model Number: 36104
• Device Catalogue Number: 36104
• Device Lot Number: JUAY0654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Date Manufacturer Received: 04/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1