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

Lot Number 16WB5000

Device Problem Component Missing (2306)

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

Event Date 01/28/2017

Event Type  malfunction  

Event Description

Medline c-section pack missing blades.Pack is supposed to have 2 blades but no blades were in the new pack when opened.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: CESAREAN SECTION TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1170 s. northpoint blvd.; waukegan IL 60085
• MDR Report Key: 6356015
• MDR Text Key: 68232141
• Report Number: 6356015
• Device Sequence Number: 1
• Product Code: OHM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2017

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 Expiration Date: 08/31/2017
• Device Lot Number: 16WB5000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/07/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1