MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER CLEAR ADVANTAGE SPIRIT HYDRO SHEATH STYLE 2 28MM BX30; MEC

Catalog Number	7283
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 states 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) 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." (b)(4).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.The device was not returned.
Event or Problem Description
It was reported that the adhesive the patch on the (clear advantage spirit hydrocolloid sheath style 2 28mm) catheter is not long enough compared to the other batches.
Additional Manufacturer Narrative
Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.
Event or Problem Description
It was reported that the adhesive the patch on the (clear advantage spirit hydrocolloid sheath style 2 28mm) catheter is not long enough compared to the other batches.

• Brand Name: ROCHESTER CLEAR ADVANTAGE SPIRIT HYDRO SHEATH STYLE 2 28MM BX30
• Common Device Name: MEC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6842606
• Report Number: 1018233-2017-04608
• Device Sequence Number: 1430315
• Product Code: NNX
• UDI-Device Identifier: 00801741071645
• UDI-Public: (01)00801741071645
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2017

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: Lay User/Patient
• Device Catalogue Number: 7283
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 09/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1