MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD MAJOR PACK #10 SURGICAL BLADE; GENERAL SURGERY TRAY

Model Number DYNJ49354

Device Problem Degraded (1153)

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

Event Date 07/27/2022

Event Type  malfunction  

Event Description

The #10 surgical blade in medline major pack with what appears to be rust, observed on the surgical blade upon opening.Fda safety report id# (b)(4).

• Brand Name: MAJOR PACK #10 SURGICAL BLADE
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 15147605
• MDR Text Key: 297163015
• Report Number: MW5111214
• 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: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: DYNJ49354
• Device Catalogue Number: DYNJ49354
• Device Lot Number: 22NBA204
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: Black Or African American