MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) BARD C-MAX CUTTING LOOP

Catalog Number 355305

Device Problems Break (1069); Product Quality Problem (1506)

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

Event Type  malfunction  

Event Description

It was reported that the device was broken in the package.

Manufacturer Narrative

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

• Brand Name: BARD C-MAX CUTTING LOOP
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON); covington GA
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON); 8195 industrial blvd.; covington GA 30014
• Manufacturer Contact: beverly schaner ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 3851965
• MDR Text Key: 20974880
• Report Number: 1018233-2014-00080
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/20/2014

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: 355305
• Device Lot Number: NGXL1514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2014
• Initial Date FDA Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: No
• 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