MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; CESAREAN SECTION TRAY

Model Number DYNJ68111

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 03/01/2021

Event Type  malfunction  

Event Description

When opening a c/s package from medline and the blue outer wrap layer had a hole.It was discarded and opened another one.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: CESAREAN SECTION TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11574398
• MDR Text Key: 242407683
• Report Number: 11574398
• Device Sequence Number: 1
• Product Code: OHM
• UDI-Device Identifier: 10193489498899
• UDI-Public: (01)10193489498899
• 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: 03/11/2021,03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYNJ68111
• Device Catalogue Number: DYNJ68111
• 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: 03/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1