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

Catalog Number DYNJ42549D

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 07/01/2019

Event Type  malfunction  

Event Description

Black winged bug found in major general pack.It was removed and a new pack opened during set up.Pt was not in the room.Pt is here for robotic sigmoidectomy.

• Brand Name: MEDLINE MAJOR GENERAL PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 8790668
• MDR Text Key: 151292991
• Report Number: MW5088099
• 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: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ42549D
• Device Lot Number: 19CLA416
• 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
• Patient Age: 77 YR