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

Model Number	774415
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.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 was missing the drainage eyes, which prevented the urine from draining.The device was replaced and no medical intervention was required.
Event or Problem Description
It was reported that the catheter was missing the drainage eyes, which prevented the urine from draining.The device was replaced and no medical intervention was required.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing related.Received 1 red urethral catheter with the original packaging for evaluation.The exterior of the sample was visually examined and found that there were no drainage eyes.A potential root cause is this may occur during the eye punching operation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.Visually inspect the product for any imperfections or surface deterioration prior to use.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box." (b)(4).

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7244331
• Report Number: 1018233-2018-00357
• Device Sequence Number: 1342831
• Product Code: EYB
• UDI-Device Identifier: 00801741040221
• UDI-Public: (01)00801741040221
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 774415
• Device Catalogue Number: 774415
• Device Lot Number: NGBW4021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1