MAUDE Adverse Event Report: AVID MEDICAL, INC., A MEDICAL ACTION IND. COMPANY 305 CUSTOM CATARACT PACK ; EYE TRAY

Catalog Number WILF013-32

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2020

Event Type  malfunction  

Event Description

Scrub tech upon opening the custom pack to prepare, observed human hair inside the sterile pack.(b)(6) operating room #3 on (b)(6) 2020 about 0715hrs.No staff or pt injured, pt hadn't rolled into the room at that time.Psr #(b)(4) submitted.Fda report filed.Certified scrub tech opened the pack.Product sterile and packed in manufactured packaging expire on 01/01/2020, lot #1382717.Product should be free of foreign debris.Vendor poc for the whasc notified, (b)(6).Fda safety report id# (b)(4).

• Brand Name: CUSTOM CATARACT PACK
• Type of Device: EYE TRAY
• Manufacturer (Section D): AVID MEDICAL, INC., A MEDICAL ACTION IND. COMPANY 305
• MDR Report Key: 9728693
• MDR Text Key: 180310886
• Report Number: MW5093066
• Device Sequence Number: 1
• Product Code: OJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: WILF013-32
• Device Lot Number: 1382717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1