MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MAJOR SINGLE BASIN WITH GOWNS PACK; TRAY, SURGICAL

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/02/2019

Event Type  malfunction  

Event Description

When preparing for an operating room case, a medline major single basin w/ gowns package was opened and the 10 count gauze 4x4 xray lap pads only had 9.These were removed from the case and this event never came into contact with a pt.Fda safety report id# (b)(4).

• Brand Name: MAJOR SINGLE BASIN WITH GOWNS PACK
• Type of Device: TRAY, SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 9208094
• MDR Text Key: 162993968
• Report Number: MW5090470
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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