MAUDE Adverse Event Report: C. R. BARD, INC. N/A; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	006172P
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
At a minimum of 5 times since the end of 2017, providers who have been using the "bard medical temporary pacing electrode catheter" have had instances of the tip of the catheter puncturing the wall of the heart, causing cases of pericardial effusion.In none of these instances did staff keep any of the packaging or any piece of the cardiac catheter kit.Providers requested a new type of catheter device, and when they began using it, the problems subsided.The new catheter kits that they were using eventually ran out of stock, causing them to go back and use the original ones that were originally causing problems for patients.At the end of 2019, after switching back to the bard medical catheters, a provider had another problem with a "bard medical temporary pacing electrode catheter.".

• Brand Name: N/A
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial drive; covington GA 30014
• MDR Report Key: 9595638
• Report Number: 9595638
• Device Sequence Number: 19442005
• Product Code: LDF
• UDI-Device Identifier: 00801741011191
• UDI-Public: (01)00801741011191
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 01/03/2020
• Report Date (Section F): 01/06/2020

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: 006172P
• Device Catalogue Number: 006172P
• Device Lot Number: GFDW3504
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/06/2020