MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; C- SECTION PACK

Device Problem Component Missing (2306)

Patient Problems Abdominal Pain (1685); Foreign Body In Patient (2687)

Event Date 12/29/2018

Event Type  malfunction  

Event Description

Patient needed an emergency cesarean section.Lap sponges were opened for the case, both the cesarean section kit and separate lap sponges.During the pre-operative count, there was found to be one lap sponge packet with 4 instead of 5 sponges.In light of the deceleration, and urgency of the case, the count was conducted 3 times and confirmed to be 4 sponges, with a total count of 24 sponges.The patient later complained of abdominal pain and ct scan showed a retained sponge.

• Type of Device: C- SECTION PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl.; mundelein IL 60060
• MDR Report Key: 8605095
• MDR Text Key: 144923650
• Report Number: 8605095
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11680 DA