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

Model Number	120616
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that few of intermittent catheters was found discolored inside the packaging.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.One 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 was unknown, it could not 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 orange coude tip catheter was returned unopened in original packaging.The catheter was noted to have multiple discoloration marks.Catheter discoloration was confirmed to be caused by oxidation.As is it unable to determine when the oxidation occurred the reported event will be confirmed cause unknown.Photo samples of the catheter was also returned.The samples also showed discoloration of the catheter caused by oxidation.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: "storage: store catheters at room temperature away from direct exposure to light, preferably in the original box".
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.One 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 was unknown, it could not 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 orange coude tip catheter was returned unopened in original packaging.The catheter was noted to have multiple discoloration marks.Catheter discoloration was confirmed to be caused by oxidation.As is it unable to determine when the oxidation occurred the reported event will be confirmed cause unknown.Photo samples of the catheter was also returned.The samples also showed discoloration of the catheter caused by oxidation.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: "storage: store catheters at room temperature away from direct exposure to light, preferably in the original box".
Event or Problem Description
It was reported that few of intermittent catheters was found discolored inside the packaging.

• Brand Name: BARD® URETHRAL CATHETER
• Common Device Name: URETHRAL 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: 13596169
• Report Number: 1018233-2022-00858
• Device Sequence Number: 1930492
• Product Code: KOD
• UDI-Device Identifier: 00801741029974
• UDI-Public: (01)00801741029974
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2022

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: 01/31/2024
• Device Model Number: 120616
• Device Catalogue Number: 120616
• Device Lot Number: NGEQ1889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2020
• 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