MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 36MM 30BX

Model Number	39304
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and 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: 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 hospital ordered mec product catalog number 39304, but when the package received was opened, mec product catalog number 39302 was contained within the package.
Event or Problem Description
It was reported that the hospital ordered mec product catalog number 39304 but when the package received was opened, mec product catalog number 39302 was contained within the package.
Additional Manufacturer Narrative
The reported event was confirmed as a packaging issue.The visual evaluation of the photo samples noted that the original box packaging had product 39304 and corporate lot number jucs0070 labeled on it.However, each individual package was labeled with product 39302 and corporate lot number jucs0073.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." correction: d10, h3, h6.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.

• Brand Name: ROCHESTER MEC SPIRIT SHEATH STYLE 3 WIDEBAND 36MM 30BX
• Common Device Name: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8203838
• Report Number: 1018233-2018-06246
• Device Sequence Number: 197468
• Product Code: NNX
• UDI-Device Identifier: 00801741071355
• UDI-Public: (01)00801741071355
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: 39304
• Device Catalogue Number: 39304
• Device Lot Number: JUCS0070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1