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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVID MEDICAL, AN OWENS & MINOR COMPANY CUSTOM EYE PLASTIC PACK GENERAL SURGERY TRAY

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AVID MEDICAL, AN OWENS & MINOR COMPANY CUSTOM EYE PLASTIC PACK GENERAL SURGERY TRAY Back to Search Results
Catalog Number WILF024-15
Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2019
Event Type  Malfunction  
Event Description

Scrub tech upon opening the custom pack to prepare, passed off the prep kit to the operating room nurse. Nurse upon opening the kit observed tiny holes in the bottom of the prep kit wrapper creating strike through of a sterile item. Whasc operating room #3 on 10/24/2019 about 0715hrs. No staff or pt injured, prep kit wrapper saved and supplies pulled from stock to complete the pt prep. (b)(4) submitted. Fda report filed. Certified scrub tech opened the pack. Product sterile and packed in manufactured packaging expire on 08/31/2021, lot #1360635. Product should be free of foreign debris and holes. Incident of this nature is not uncommon and/ is continued to be reported as they occur. Vendor poc for the whasc notified. (b)(6). Fda safety report id# (b)(4).

 
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Brand NameCUSTOM EYE PLASTIC PACK
Type of DeviceGENERAL SURGERY TRAY
Manufacturer (Section D)
AVID MEDICAL, AN OWENS & MINOR COMPANY
toano VA 23168
MDR Report Key9260456
MDR Text Key164840873
Report NumberMW5090785
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/28/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/30/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberWILF024-15
Device LOT Number1360635
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/28/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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