MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® TOUCHLESS® URETHRAL CATHETER KIT WITH RED RUBBER CATHETER; TOUCHLESS MALE CATHETER

Model Number	4A3053
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Codes	No Patient Involvement (2645); 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 iodine "busted" in the kit.
Additional Manufacturer Narrative
The reported event was confirmed as cause unknown.The visual evaluation of the returned sample noted one touchless male urethral catheter kit with open original packaging.Iodine was noted to have penetrated the packaging and the contents within.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: "open package of povidone-iodine swabs as directed." 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 iodine "busted" in the kit.

• Brand Name: BARD® TOUCHLESS® URETHRAL CATHETER KIT WITH RED RUBBER CATHETER
• Common Device Name: TOUCHLESS MALE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8350523
• Report Number: 1018233-2019-00863
• Device Sequence Number: 2010155
• Product Code: FCM
• UDI-Device Identifier: 00801741030680
• UDI-Public: (01)00801741030680
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K910653
• 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): 05/13/2019

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 Expiration Date: 02/28/2021
• Device Model Number: 4A3053
• Device Catalogue Number: 4A3053
• Device Lot Number: NGBZ2688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1