MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM WITH BARD® LUBRI-SIL® CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number	A942208
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
While preparing pt.For procedure an 8fr foley catheter (ref: a942208, lot: ngdq3696) was inserted.Sterile technique was maintained when inserting the foley catheter.After verifying the balloon port size (5ml) the circulator injected 5ml of sterile water into the balloon port.It was noted there was no resistance and after verifying placement (urine was emptying into the foley container) the foley catheter came all the way out with balloon deflated and sterile water coming out of the balloon.The foley catheter and sterile field were taken down and thrown out.A new 8 fr.Foley catheter was placed with no complications.Packaging was kept by circulator and clinician was notified.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM WITH BARD® LUBRI-SIL® CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 9109222
• Report Number: 9109222
• Device Sequence Number: 3041793
• Product Code: EZL
• UDI-Device Identifier: 00801741100550
• UDI-Public: (01)00801741100550
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2019
• Report Date (Section F): 08/30/2019

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: Other
• Device Model Number: A942208
• Device Catalogue Number: A942208
• Device Lot Number: NGDQ3696
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 9
• Date Report Sent to FDA: 08/30/2019