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

Model Number	A942214
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A foley (urinary) catheter expulsed during a caesarian section procedure.The balloon was intact.Manufacturer response for surestep foley catheter tray, surestep (per site reporter) we met with the manufacturer representatives about this and several other failures of foley catheters.The manufacturer representative noted there is an identified problem with the vent of the new design of the surestep foley catheter system.They have reverted back to the prior ventless product although there are still some vented catheters available in the supply stream.We gave the representative several other catheters and will await analysis by the manufacturer's quality dept.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER TRAY
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8132449
• Report Number: 8132449
• Device Sequence Number: 19374687
• Product Code: EZL
• UDI-Device Identifier: 00801741074103
• UDI-Public: (01)00801741074103
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/29/2018
• Report Date (Section F): 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: A942214
• Device Catalogue Number: A942214
• Device Lot Number: 175814 NGCQ0216
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 97
• Date Report Sent to FDA: 11/29/2018