MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. CHEST THORASCOPY PACK; GENERAL SURGERY TRAY

Catalog Number CMPJ37658I

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2020

Event Type  malfunction  

Event Description

Chest thorascopy pack was being counted by the rn and cst in the room.The pack is to have 15 lap sponges in the pack; however, 16 sponges were counted.Fda safety report id# (b)(4).

• Brand Name: CHEST THORASCOPY PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 10501219
• MDR Text Key: 206148092
• Report Number: MW5096448
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: CMPJ37658I
• Device Lot Number: 19HBI195
• 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