MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; DRAPE FROM OFF PUMP CABG PACK

Catalog Number	DYNJ904666A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a foam portion of the drape, which surrounds the drape's chest opening, fell apart into surgical site (chest).Per report, the drape was being used during the case and upon removal to the clamps (holds the pericardium up/open), holding the 2-o silk suture, a piece fell into the patient's chest.The incident reportedly happened ¾ of the way through the procedure.The piece of foam from the drape was reportedly successfully retrieved from the patient's chest through use of forceps.No impact to the patient, the staff, or the total length of the procedure was reported.There was no serious injury reported related to the event.Due to the reported incident and required medical intervention to retrieve the foam from the patient's chest, this medwatch is being filed.An unused companion sample was returned for evaluation and the complaint could not be confirmed.A definitive root cause could not be identified at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a foam portion of the drape fell apart into surgical site and this was successfully retrieved through use of forceps.

• Common Device Name: DRAPE FROM OFF PUMP CABG PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8381874
• Report Number: 1423395-2019-00003
• Device Sequence Number: 16198652
• Product Code: OEZ
• UDI-Device Identifier: 10889942807819
• UDI-Public: 10889942807819
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/01/2019

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: DYNJ904666A
• Device Lot Number: 18JDD446
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 03/01/2019
• 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