MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; CARDIAC - KORVER

Catalog Number	DYNJ902535J
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the customer was undergoing a coronary artery bypass grafting (cabg), mitral valve replacement and maze and in the middle of the procedure the tip of the blower was noted to be missing from the device.It is unknown if the tip blew off in the patient or outside of the patient.The patient was discharged home with no complications reported.No additional details are available.The blue tip is not available to be returned for evaluation.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the customer was undergoing a cardiac procedure and in the middle of the procedure the tip of the blower was noted to be missing from the device.It is unknown if the tip blew off in the patient or outside of the patient.
Additional Manufacturer Narrative
Additional information: a photo and a sample of two soft tips were received for investigation, the rest of the pack was not received at this time.Upon inspection of the received samples it was seen that on one of the samples returned the tip was off of the end of the soft tip.The other sample that was returned for investigation appears to have the tip intact and there appears to be no damage.A root cause was determined to be a vendor product issue and the samples were forwarded to the vendor for further evaluation.If additional relevant information becomes available another supplemental mdr will be filed.

• Common Device Name: CARDIAC - KORVER
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11361539
• Report Number: 1423395-2021-00011
• Device Sequence Number: 4568009
• Product Code: OEZ
• UDI-Device Identifier: 10193489335101
• UDI-Public: 10193489335101
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ902535J
• Device Lot Number: 20GKA661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Received by Manufacturer: 01/26/2021
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Weight: 98