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

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 05/09/2014

Event Type  malfunction  

Event Description

During open heart surgery, one side of a hemostat jaw was found to be broken off after use in the procedure.After a thorough field and floor search were conducted without success, radiology was called to perform fluoroscopy.The foreign body was located and removed from the patient's thoracic cavity.There is no information for the manufacturer-address, age, serial number, model number and lot number.The device is available at nch for evaluation.The manufacturer has not been made aware.

• Brand Name: V. MUELLER HEMOSTAT
• Type of Device: HEMOSTAT, SURGICAL
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 3893499
• MDR Text Key: 4540451
• Report Number: 3893499
• Device Sequence Number: 1
• Product Code: HRQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/11/2014

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: Physician
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/11/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 79