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

Model Number	A902416
Health Effect - Clinical Code	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 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 iodine packet had burst in the foley tray.
Event or Problem Description
It was reported that the iodine packet had burst in the foley tray.
Additional Manufacturer Narrative
The reported event was confirmed.Received 1 opened surestep foley tray system for evaluation.During the visual inspection, it was noted that the iodine package had a small cut in one side.The damage measured 0.136".The package presented a leak by this small cut and contaminated the tray.The root cause of the damage could not be determined.The damage could have occurred during handling or transportation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states 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." 1267: "l" 2645: "nl".

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® ALL- SILICONE FOLEY CATHETER TRAY
• Common Device Name: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7287900
• Report Number: 1018233-2018-00506
• Device Sequence Number: 1671246
• Product Code: EZL
• UDI-Device Identifier: 00801741074042
• UDI-Public: (01)00801741074042
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2018

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: A902416
• Device Catalogue Number: A902416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1