MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; OPEN HEART PACK

Catalog Number	DYNJ47493D
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that when going to drape a patient, a lizard was found on the drape adhesive.The procedure being performed was a cabg with aortic valve.Reportedly, the entire operating room was torn down and a new set up was required.According to the facility, the procedure was delayed for one (1) hour and fifteen (15) minutes.It was reported that the patient was under general anesthesia when the lizard was discovered.The patient required additional anesthesia to complete the procedure.No serious injury, follow-up care, or additional medical intervention was reported.The original pack sample was reportedly discarded and was not returned to the manufacturer for evaluation.The lizard was returned to the manufacturer.No information was provided regarding the lizard's location on the drape adhesive.Due to the need for additional anesthesia, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be field.
Event or Problem Description
It was reported that when going to drape a patient, a lizard was found on the drape adhesive.

• Common Device Name: OPEN HEART PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7374416
• Report Number: 1423395-2018-00013
• Device Sequence Number: 16571746
• Product Code: OEZ
• UDI-Device Identifier: 10889942324743
• UDI-Public: 10889942324743
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2018

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: Physician
• Device Catalogue Number: DYNJ47493D
• Device Lot Number: 17ZB3263
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 03/27/2018
• 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