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

Model Number	A800060
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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 information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device was not returned.
Event or Problem Description
It was reported that of the two cases ordered, one case arrived labeled as a800060 but had a feeding pump set inside of it.
Additional Manufacturer Narrative
The reported event could not be confirmed as no sample was returned for evaluation.A potential failure mode could be ¿incorrect product labeling (box label)¿ with a potential root cause of "incorrect labeling supply".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use." section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that of the two cases ordered, one case arrived labeled as a800060 but had a feeding pump set inside of it.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRICATH FOLEY
• Common Device Name: FOLEY KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8981445
• Report Number: 1018233-2019-05488
• Device Sequence Number: 16853410
• Product Code: EZC
• UDI-Device Identifier: 00801741096624
• UDI-Public: (01)00801741096624
• Combination Product (Y/N): N
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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 Model Number: A800060
• Device Catalogue Number: A800060
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1