MAUDE Adverse Event Report: MEDLINE INDUSTRIES - MUNDELEIN LOU MAJOR PROCEDURE PACK; GENERAL SURGERY TRAY

Catalog Number CMPJ05335G

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2020

Event Type  malfunction  

Event Description

Opened lou major procedure pack for procedure.Scrub tech pulled back paper from foam component of needle book to adhere it to his mayo and discovered what appeared to be a dead insect adhered to the sticky side of the foam.Fda safety report id # (b)(4).

• Brand Name: LOU MAJOR PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES - MUNDELEIN
• MDR Report Key: 10816475
• MDR Text Key: 216192055
• Report Number: MW5097760
• Device Sequence Number: 1
• Product Code: LRO
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CMPJ05335G
• Device Lot Number: 20DBR165
• 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: 57 YR
• Patient Weight: 55