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

Lot Number 17AB7412

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 05/04/2017

Event Type  malfunction  

Event Description

Upon opening for a case the scrub tech found a dead fly on one of the laps in a c-section pack.Per site reporter: medline initiated a quality review investigation and supplied us with replacement product.

• 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: 6861422
• MDR Text Key: 85942304
• Report Number: 6861422
• 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: 08/11/2017,08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Lot Number: 17AB7412
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1