MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. BASIC SPINE PACK-PITCHER; GENERAL SURGERY TRAY

Catalog Number REF-CMPJ08200B

Device Problem Break (1069)

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

Event Date 10/07/2020

Event Type  malfunction  

Event Description

Had 2 medline basic spine pack with broken plastic pitchers in the packs.Pitchers were taken off the field prior to case(s) starting.Fda safety report id# (b)(4).

• Brand Name: BASIC SPINE PACK-PITCHER
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 10791708
• MDR Text Key: 215034877
• Report Number: MW5097652
• 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: 11/02/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2021
• Device Catalogue Number: REF-CMPJ08200B
• Device Lot Number: 20BBS082
• 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