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

Model Number DYNJ04393G

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 01/07/2022

Event Type  malfunction  

Event Description

Procedure to be done was exploratory laparotomy, sigmoid resection.While doing initial count for lap sponges from major pack, noted with extra lap sponges.Instead with 10 lap sponges, it comes with 11 sponges.Sequestered the item and reported to my supervisor.Major pack ref# (b)(4), lot # 21lma588.

• 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: 13710074
• MDR Text Key: 286855463
• Report Number: 13710074
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/02/2022,02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ04393G
• Device Catalogue Number: DYNJ04393G
• Device Lot Number: 21LMA588
• 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: 03/02/2022
• Date Report to Manufacturer: 03/09/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Female