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

Model Number DYNJ04631R

Device Problem Component Missing (2306)

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

Event Date 04/20/2020

Event Type  malfunction  

Event Description

Clamp umbilical cord and medicine cup missing from medline vaginal delivery pack.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: LABOR AND DELIVERY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 10020180
• MDR Text Key: 189734625
• Report Number: 10020180
• Device Sequence Number: 1
• Product Code: MLS
• UDI-Device Identifier: 10193489602227
• UDI-Public: (01)10193489602227
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYNJ04631R
• Device Catalogue Number: DYNJ04631R
• Device Lot Number: (01)19KMB158
• 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: 04/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1