MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP FOLEY TRAY SYSTEM BARD LUBRICATH FOLEY

Model Number	A800361
Medical Device Problem Codes	Inadequate Instructions for Healthcare Professional (1319); Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
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 the product did not visibly state that it was made of latex.This had led to confusion and incorrect catheter placement.Hence the latex warning was inside of the packaging and the customer preferred to be on the exterior.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "missing instructions".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labelling could not have prevented the reported failure.The device was not returned.
Event or Problem Description
It was reported that the product did not visibly state that it was made of latex.This had led to confusion and incorrect catheter placement.Hence the latex warning was inside of the packaging and the customer preferred to be on the exterior.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM BARD LUBRICATH FOLEY
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11396364
• Report Number: 1018233-2021-00878
• Device Sequence Number: 16449003
• Product Code: EZC
• UDI-Device Identifier: 00801741073939
• UDI-Public: (01)00801741073939
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2021

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: Lay User/Patient
• Device Expiration Date: 10/31/2022
• Device Model Number: A800361
• Device Catalogue Number: A800361
• Device Lot Number: NGEQ4267
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other