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

Catalog Number DYNOJ046310

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

When staff was opening for a vaginal delivery, it was noted there were 15 lap sponges in the pack (supposed to be 10).

• Brand Name: MEDLINE LABOR AND DELIVERY KIT
• Type of Device: LABOR AND DELIVERY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 5623539
• MDR Text Key: 44139319
• Report Number: 5623539
• 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: 04/28/2016

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: 12/31/2016
• Device Catalogue Number: DYNOJ046310
• Device Lot Number: 16MB7489
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1