MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED RUBBER URETHRAL CATHETER KIT

Model Number	4A5044
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 unopened and 2 used bard touchless urethral catheter kits for evaluation.The reported event was unconfirmed as the problem could not be reproduced.The exterior of the sample was visually inspected and did not find any evidence of a failure that would support the reported event.Per the dimensional evaluation, it was found all three samples were within specification for 14 french size.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 catheter seems wider than usual, making it more difficult to insert.Reason for report: investigation results.(b)(4).Initial asr report submitted: quarter 1/2018.Corresponding exemption number: e1997042.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED RUBBER URETHRAL CATHETER KIT
• Common Device Name: CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7750528
• Report Number: 1018233-2018-03319
• Device Sequence Number: 1939187
• Product Code: FCM
• UDI-Device Identifier: 00801741030512
• UDI-Public: (01)00801741030512
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• 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: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: 4A5044
• Device Catalogue Number: 4A5044
• Device Lot Number: NGBX4501
• 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