MAUDE Adverse Event Report: CAREFUSION 2200, INC. V. MUELLER; INSTRUMENT, SURGICAL, DISPOSABLE

Model Number CH 2520/ XRBG02

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/28/2017

Event Type  malfunction  

Event Description

The carbide bit for the needle driver came off and was unintentionally retained in the patient.

• Brand Name: V. MUELLER
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 6571959
• MDR Text Key: 75343330
• Report Number: 6571959
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CH 2520/ XRBG02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR