MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) BARD PLATINUM CLASS FLAT WIRE STONE BASKET

Catalog Number 045390

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Information (3190)

Event Date 04/17/2014

Event Type  malfunction  

Event Description

It was reported the tip fell off during pretesting.

Manufacturer Narrative

Investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

• Brand Name: BARD PLATINUM CLASS FLAT WIRE STONE BASKET
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON); covington GA
• Manufacturer (Section G): C.R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 3915694
• MDR Text Key: 20979579
• Report Number: 1018233-2014-00154
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: 045390
• Device Lot Number: BMXJM030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/21/2014
• Initial Date FDA Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1