MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. COMPLETE CARE® FOLEY CATHETER TRAY AND URINE METER

Model Number	303316A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
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.The device was not returned.
Event or Problem Description
It was reported that three antiseptic swab sticks were not in the foley kit.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.It is unknown whether the device had met relevant specifications.Based on no patient involvement the product does not appear to have been used.However, the product is intended to be used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be ¿incorrect operation¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review is not required because labeling could not have prevented this issue.The device was not returned.
Event or Problem Description
It was reported that three antiseptic swab sticks were not in the foley kit.

• Brand Name: BARDEX® I.C. COMPLETE CARE® FOLEY CATHETER TRAY AND URINE METER
• Common Device Name: FOLEY CATHETER TRAY
• 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: 12615372
• Report Number: 1018233-2021-06337
• Device Sequence Number: 1453351
• Product Code: MJC
• UDI-Device Identifier: 00801741024269
• UDI-Public: (01)00801741024269
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• 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): 04/19/2022

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: 05/31/2023
• Device Model Number: 303316A
• Device Catalogue Number: 303316A
• Device Lot Number: NGFN4251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• 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