MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; OR TOWEL IN VITRECTOMY PACK

Catalog Number	DYNJ56586D
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during a 25g vitrectomy, lint from the operating room towel fell into the patient's eye.This incident reportedly occurred at the start of the procedure and the physician was required to remove the operating room towel lint from the patient's eye with a pair of tweezers.The 25g vitrectomy was completed without further reported incident.The procedure did not run longer than expected and the patient did not require additional anesthesia.No patient injury related to this incident was reported.No sample was available to be returned to the manufacturer for evaluation.A root cause cannot be determined.Due to the need for medical intervention to remove the operating room towel lint from the patient's eye, 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 25g vitrectomy, lint from the operating room towel fell into the patient's eye.

• Common Device Name: OR TOWEL IN VITRECTOMY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 7784622
• Report Number: 1423395-2018-00042
• Device Sequence Number: 19155074
• Product Code: LRO
• UDI-Device Identifier: 10888277774469
• UDI-Public: 10888277774469
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/15/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ56586D
• Device Lot Number: 18FBU545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/15/2018
• 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: Other