MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. MAXCORE DISPOSABLE BIOPSY SYSTEM

Catalog Number MC1820

Device Problems Failure to Reset (1532); Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that when exposing the core sample the gun would not click back up and misfired.There was no patient impact.

Manufacturer Narrative

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

• Brand Name: MAXCORE DISPOSABLE BIOPSY SYSTEM
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V.; reynosa, tamaulipas ; MX
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4196589
• MDR Text Key: 19973900
• Report Number: 1018233-2014-00275
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K874585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/23/2014

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: MC1820
• Device Lot Number: REYC2853
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/07/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2014
• Initial Date FDA Received: 10/17/2014
• 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