MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® RUBBER UTILITY CATHETER

Model Number	277718
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.As the device had signs of degradation, the reported event is confirmed to have a relationship with the device.As the cause of this issue is unknown, it cannot be determined if the device met specifications.As the product was not used on a patient, it was not used for diagnostic or treatment purposes.An applicable risk region and failure mode will be addressed in a future revision of afmea.A red ureteral catheter was returned opened in original packaging.The catheter was noted to contain white discoloration and white striped discoloration caused by oxidation of the catheter.As is it unable to determined when the oxidation occurred the reported event will be confirmed cause unknown.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.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: warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.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.Caution: this product contains natural rubber latex which may cause allergic reactions.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.
Event or Problem Description
It was reported that the 4 red rubber catheters that had a white coating on them and customer did not feel comfortable using catheter.The lot number which had white coating are ngbr2101 ,ngcp2353, ngew2357 and ngeq1812.

• Brand Name: BARD® RUBBER UTILITY CATHETER
• Common Device Name: RUBBER UTILITY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13558723
• Report Number: 1018233-2022-00694
• Device Sequence Number: 4195057
• Product Code: KOD
• UDI-Device Identifier: 00801741034121
• UDI-Public: (01)00801741034121
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2022

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: 11/30/2021
• Device Model Number: 277718
• Device Catalogue Number: 277718
• Device Lot Number: NGBR2101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown