MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. PLASTIC MAJOR PACK; GENERAL SURGERY TRAY

Model Number DYNJ49360

Device Problems Break (1069); Material Discolored (1170)

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

Event Date 10/07/2019

Event Type  malfunction  

Event Description

Upon opening medline plastic major pack, the surgical sponges were found to be discolored and the skin stapler was broken in two pieces.Fda safety report id# (b)(4).

• Brand Name: PLASTIC MAJOR PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL 60093
• MDR Report Key: 9472964
• MDR Text Key: 171552998
• Report Number: MW5091675
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: DYNJ49360
• Device Catalogue Number: DYNJ49360
• Device Lot Number: 19EBV699
• Was Device Available for Evaluation?: Yes
• 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