MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; LABOR AND DELIVERY KIT

Model Number	DYNJ04631R
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Clamp umbilical cord and medicine cup missing from medline vaginal delivery pack.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: LABOR AND DELIVERY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 10020180
• Report Number: 10020180
• Device Sequence Number: 2502630
• Product Code: MLS
• UDI-Device Identifier: 10193489602227
• UDI-Public: (01)10193489602227
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2020
• Report Date (Section F): 04/24/2020

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
• Operator of Device: No Information
• Device Model Number: DYNJ04631R
• Device Catalogue Number: DYNJ04631R
• Device Lot Number: (01)19KMB158
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/24/2020