MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP ASC SELECT PACK INCISE

Model Number	LYN030INSPA
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that there is fabric around the eye shield, and even though everything is pre-rinsed the fibers still show up.The facility has to open new syringes to prevent fibers from getting in the patients eyes.Particulate was in the eye and removed with tying forceps.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample was not returned to the manufacturer for evaluation.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 there is fabric around the eye shield, and even though everything is pre-rinsed the fibers still show up.The facility has to open new syringes to prevent fibers from getting in the patients eyes.Particulate was in the eye and removed with tying forceps.

• Brand Name: ASC SELECT PACK INCISE
• Common Device Name: ASC SELECT PACK INCISE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15136749
• Report Number: 1423395-2022-00027
• Device Sequence Number: 12586755
• Product Code: LRO
• UDI-Device Identifier: 10193489290998
• UDI-Public: 10193489290998
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2022

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 Model Number: LYN030INSPA
• Device Catalogue Number: LYN030INSPA
• Device Lot Number: 21DBU693
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 07/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown