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

Model Number DYNJ04716Q

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 10/17/2022

Event Type  malfunction  

Event Description

The operating room team found that there were 11 lap sponges in a pack that was labeled 10 count.Lap sponges are counted in sets of 10.An inconsistent count is a risk for a retained surgical item.

• Brand Name: MAJOR LITHOTOMY PACK-LF
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15796697
• MDR Text Key: 303699061
• Report Number: 15796697
• 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: 10/31/2022,10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ04716Q
• Device Catalogue Number: DYNJ04716Q
• Device Lot Number: 22GMA103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2022
• Date Report to Manufacturer: 11/15/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1