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

Catalog Number DYNJ24831F

Device Problems Incomplete or Missing Packaging (2312); Packaging Problem (3007)

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

Event Date 03/10/2016

Event Type  malfunction  

Event Description

In the c-section pack from medline industries, reorder# dynj24831f, lot# 15jb9754, exp date: 06/30/2016, there were only two packs of blades.In one pack there were two blades, so the total count was three blades instead of the intended two blades.

• Type of Device: C-SECTION PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES; one medline place; mundelein, IL 60060
• MDR Report Key: 5633463
• MDR Text Key: 44461519
• Report Number: 5633463
• Device Sequence Number: 1
• Product Code: LRO
• 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: 03/15/2016,03/29/2016

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: 06/30/2016
• Device Catalogue Number: DYNJ24831F
• Device Lot Number: 15JB9754
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1