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

Model Number DYNJ04620R

Device Problem Component Missing (2306)

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

Event Date 09/09/2020

Event Type  malfunction  

Event Description

Upon opening sterile c-section pack for c-section noted missing items.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: CESAREAN SECTION TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 10585845
• MDR Text Key: 208526796
• Report Number: 10585845
• Device Sequence Number: 1
• Product Code: OHM
• 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: 09/11/2020

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: Health Professional
• Device Model Number: DYNJ04620R
• Device Catalogue Number: DYNJ04620R
• Device Lot Number: (10) 20HMA750
• 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: 09/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1