MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. LOU C-SECTION KIT; CESAREAN SECTION TRAY

Catalog Number DYNJ901840C

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 09/11/2020

Event Type  malfunction  

Event Description

Opened second kit after dust in the first one and found multiple tears in sterile wrapping.Fda safety report id# (b)(4).

• Brand Name: LOU C-SECTION KIT
• Type of Device: CESAREAN SECTION TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL
• MDR Report Key: 10540373
• MDR Text Key: 207383371
• Report Number: MW5096654
• Device Sequence Number: 1
• Product Code: OHM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• 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 Expiration Date: 10/31/2021
• Device Catalogue Number: DYNJ901840C
• Device Lot Number: 20ABU007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1