MAUDE Adverse Event Report: CAREFUSION DECKER RONGEUR CUP 2 X 6MM STR 6IN

Model Number NL6250

Device Problem Break (1069)

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

Event Date 09/10/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015 customer advocacy sent the customer an email acknowledging receipt of the complaint, providing the complaint number, and inquiring if additional information may be available.Confirmation was also requested from the customer that there was no patient impact associated with reported issue.Customer advocacy contact information was provided.Device not yet evaluated, if the device is evaluated a follow up will be sent.

Event Description

Customer reported via email that tip broke off inside the patient and they had to fish it out.On (b)(6) 2015 additional information was obtained.The tip broke off during a lumber one level procedure.A c-arm x-ray was used to verify.There was no patient impact and the procedure was completed as planned.

• Brand Name: DECKER RONGEUR CUP 2 X 6MM STR 6IN
• Type of Device: RONGEUR
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills 60061
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5140118
• MDR Text Key: 28261511
• Report Number: 1423507-2015-00045
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: NL6250
• Device Lot Number: XWAV02
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1