MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. - SPT MAJOR SINGLE BASIN W/ GOWNS PACKAGE; TRAY, SURGICAL, INSTRUMENT

Lot Number (10)19HBF740

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2019

Event Type  malfunction  

Event Description

When prepping the operating room for a new case, the major single basin w/ gowns package was found to have 4 lap sponge x-ray pads instead of the listed 5.This was removed from rotation and not included in the case.Fda safety report id# (b)(4).

• Brand Name: MAJOR SINGLE BASIN W/ GOWNS PACKAGE
• Type of Device: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. - SPT
• MDR Report Key: 9341323
• MDR Text Key: 167168180
• Report Number: MW5091151
• 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: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: (10)19HBF740
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 60