MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® ALL- SILICONE FOLEY CATHETER TRAY; SURESTEP FOLEY TRAY

Model Number	A897516
Health Effect - Clinical Code	No Information (3190)
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 bard 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 bard.
Event or Problem Description
It was reported that the foley tray was missing the povidone-iodine packet.
Event or Problem Description
It was reported that the foley tray was missing the povidone-iodine packet.
Additional Manufacturer Narrative
The reported issue (it was reported that the foley tray was missing the povidone-iodine packet) was confirmed, as cause unknown.During visual evaluation it was found that the next components were not present in the received sample: csr wrap, drape, gloves (pair), 1 single level tray, 10% povidone iodine solution packet, sticky belly band, orange label, insert folded for bard single level foley generic label, and patient education card catheter.The root cause of missing components could not be determined.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use 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." (b)(4).

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® ALL- SILICONE FOLEY CATHETER TRAY
• Common Device Name: SURESTEP FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7241706
• Report Number: 1018233-2018-00337
• Device Sequence Number: 1043830
• Product Code: EZL
• UDI-Device Identifier: 00801741073984
• UDI-Public: (01)00801741073984
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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: A897516
• Device Catalogue Number: A897516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 03/09/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1