MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER

Model Number	772416
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per direction by fda in a letter dated, july 20, 2018, this emdr is being filed to submit new information obtained based on the complaint investigation results.The initial report for this event was submitted in the quarter 1 2018 asr report.However, supplemental reports regarding the asr are no longer being accepted.It was agreed upon with the fda that the date of awareness would be the date of the letter received, which is july 20, 2018.Received 1 urethral catherization tray.Visual inspection noted that the iodine packet appeared to have a hole in it.A hole that measured 0.325" was found on the iodine packet.The iodine packet leaked on gloves, and under pad.The reported event was confirmed with an unknown cause.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 or Problem Description
It was reported that the povidone-iodine swabs leaked within the catheter kit.The leak was reportedly noticed by staff upon opening the catheter kit.Reason for report: investigation results.(b)(4).Initial asr report submitted: quarter 1/2018.Corresponding exemption number: e1997042.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH PLASTIC CATHETER
• Common Device Name: PLASTIC CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7750741
• Report Number: 1018233-2018-03347
• Device Sequence Number: 1678306
• Product Code: KOD
• UDI-Device Identifier: 00801741030420
• UDI-Public: (01)00801741030420
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 772416
• Device Catalogue Number: 772416
• Device Lot Number: NGBZ0923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 08/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1