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

Model Number DYNJ49354

Device Problem Material Puncture/Hole (1504)

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

Event Date 03/03/2021

Event Type  malfunction  

Event Description

Medline major pack currently utilizing a substitute, lesser quality, table cover due to availability issues.The substitute table cover was opened and discovered to have a hole.However, the outer dust cover was intact.Fda safety report id # (b)(4).

• Brand Name: MAJOR PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES - MUNDELEIN
• MDR Report Key: 11435297
• MDR Text Key: 238872326
• Report Number: MW5099832
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: DYNJ49354
• Device Catalogue Number: DYNJ49354
• Device Lot Number: 20LBN153
• 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: 65 YR