MAUDE Adverse Event Report: CAREFUSION, INC RETRACTOR SET W/ARM ATTACH; CARDIOVASCULAR DEVICES

Catalog Number CH8800-50

Device Problem Break (1069)

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

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).On 30apr2019 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.

Event Description

The following information was received via email: the item snapped in half during surgery.On 30apr2019 additional information: what was the procedure that was being performed? cabbage.Did any part the instrument fall into the patient¿s body, and if so, how was it retrieved? instrument was in patient chest cavity when is broke.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no.What was the patient¿s outcome? surgery completed.Was the procedure completed as planned? yes, with another mitral valve retractor.Can you please send all parts of the instrument for evaluation? yes.Do you have the lot number? vtkz 103l.No further information available.

Manufacturer Narrative

The root cause is determined to be from improper maintenance.The product was within specification when it was manufactured.There were no issues identified with the material or manufacturing process that would have contributed to the reported issue.H3 other text : see h10.

Event Description

The following information was received via email: the item snapped in half during surgery.30apr2019 additional information: 1.What was the procedure that was being performed? cabbage.2.Did any part the instrument fall into the patient¿s body, and if so how was it retrieved? instrument was in patient chest cavity when is broke.3.Was there a medical procedure performed to verify if the instrument was in the patient¿s body, such as an x-ray? no.4.What was the patient¿s outcome? surgery completed.5.Was the procedure completed as planned? yes with another mitral valve retractor 6.Can you please send all parts of the instrument for evaluation? yes.7.Do you have the lot number? vtkz 103l.

• Brand Name: RETRACTOR SET W/ARM ATTACH
• Type of Device: CARDIOVASCULAR DEVICES
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 8600222
• MDR Text Key: 180190843
• Report Number: 1423507-2019-00008
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/15/2019

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: CH8800-50
• Device Lot Number: VTKZ 103L
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 04/26/2019
• Supplement Dates FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other