MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. SPINE PACK; ORTHOPEDIC TRAY

Catalog Number CYNJV0072P

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/09/2020

Event Type  malfunction  

Event Description

There were 11 raytex gauze in the package and there should have been 10 for counting purposes.Potential for retained object.

• Brand Name: SPINE PACK
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 10482243
• MDR Text Key: 205296193
• Report Number: 10482243
• Device Sequence Number: 1
• Product Code: OJH
• 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: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CYNJV0072P
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1