MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES, INC.; TRAY, SURGICAL

Catalog Number ORHS070-12

Device Problems Component Missing (2306); Packaging Problem (3007)

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

Event Date 08/22/2014

Event Type  malfunction  

Event Description

Upon opening an implant tray, it was noted that the 50cc bulb syringe was missing.A 60cc syringe was used in place of the bulb syringe.

• Type of Device: TRAY, SURGICAL
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES, INC.; 25 heywood rd.; arden NC 28704
• MDR Report Key: 4091406
• MDR Text Key: 22262801
• Report Number: 4091406
• Device Sequence Number: 1
• Product Code: FSM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: ORHS070-12
• Device Lot Number: 966252
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2014
• Patient Sequence Number: 1