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

Model Number 006172P

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2019

Event Type  malfunction  

Event 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
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial drive; covington GA 30014
• MDR Report Key: 9595638
• MDR Text Key: 175219606
• Report Number: 9595638
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 00801741011191
• UDI-Public: (01)00801741011191
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2020,01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 006172P
• Device Catalogue Number: 006172P
• Device Lot Number: GFDW3504
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29565 DA