MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; DRAPE,CV,UNFENESTRATED,STERILE

Catalog Number	DYNJP4001
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during a mitral valve repair, the drape shed foam into the surgical site.The physician was required to remove the foam material from the surgical site with suction and forceps.The patient was under general anesthesia at the time of the incident.The procedure did not last longer than expected and the patient did not require additional anesthesia.No impact to the patient or the patient's stability was reported to the manufacturer.Reportedly, the drape involved in this incident was discarded.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the reported incident and the need for medical intervention to remove the foam material from the surgical site, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during a mitral valve repair, the drape shed foam into the surgical site.

• Common Device Name: DRAPE,CV,UNFENESTRATED,STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8102509
• Report Number: 1423395-2018-00060
• Device Sequence Number: 2027117
• Product Code: PUI
• UDI-Device Identifier: 10080196740680
• UDI-Public: 10080196740680
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/26/2018

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: DYNJP4001
• Device Lot Number: 45018070267HJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 11/26/2018
• 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: Required Intervention