MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2"; CUNNINGHAM CLAMP

Catalog Number	004053
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that the cunningham clamp was larger than 2 inches.
Additional Manufacturer Narrative
Upon further review, bard medical/bd has determined that this mdr was initially reported in error as this event is not reportable.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.
Event or Problem Description
It was reported that the cunningham clamp was larger than 2 inches.

• Brand Name: BARD CUNNINGHAM MALE INCONTINENCE PENILE CLAMP, MEDIUM 2"
• Common Device Name: CUNNINGHAM CLAMP
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8509362
• Report Number: 1018233-2019-01933
• Device Sequence Number: 1724113
• Product Code: FHA
• UDI-Device Identifier: 00801741072758
• UDI-Public: (01)00801741072758
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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: Lay User/Patient
• Device Catalogue Number: 004053
• Device Lot Number: BMCYGS04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1