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

Model Number	772415
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
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.
Event or Problem Description
It was reported that the red rubber foley in the straight catheter kit was blocked and does not drain.After the catheter failed, the customer tried to flush water but not able to flush.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.The device did not fail to meet relevant specifications.The product was used for treatment purposes.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.A red rubber catheter was returned opened with original tray labeling.No visual defects were noted.Using a slip tip syringe, di water was able to be passed through the drainage funnel.No occlusion was noted.No flat/inverted funnel was noted.Based on the results of the investigation no additional action is required at this time.A dhr review is not required as the reported event is unconfirmed.As the reported event is unconfirmed a labeling review is not required.The actual/suspected device was inspected.
Event or Problem Description
It was reported that the red rubber foley in the straight catheter kit was blocked and does not drain.After the catheter failed, the customer tried to flush water but not able to flush.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER
• Common Device Name: URETHRAL CATHETERIZATION TRAY WITH RED RUBBER 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: 12309634
• Report Number: 1018233-2021-04922
• Device Sequence Number: 17358673
• Product Code: KOD
• UDI-Device Identifier: 00801741030413
• UDI-Public: (01)00801741030413
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 03/28/2022
• 2 Devices were Involved in the Event: 1 2

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: 07/31/2023
• Device Model Number: 772415
• Device Catalogue Number: 772415
• Device Lot Number: NGFP0800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2021
• 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