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

Catalog Number DYNJ04443L

Device Problems Product Quality Problem (1506); Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2021

Event Type  malfunction  

Event Description

During initial count it was discovered the major pack contained only 9 laps instead of 10 and the 10b pack contained 2 blades instead of 1.

• Brand Name: MAJOR PACK-LF
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 13341994
• MDR Text Key: 284363376
• Report Number: 13341994
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2022,11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYNJ04443L
• Device Lot Number: 21HMG119
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/11/2022
• Date Report to Manufacturer: 01/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32850 DA
• Patient Sex: Female