MAUDE Adverse Event Report: REHRIG PACIFIC COMPANY REHRIG PACIFIC; CONTAINER, SHARPS

Model Number TS (PATIENT ROOM)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/03/2016

Event Type  malfunction  

Event Description

Patient was able to remove lid from reusable sharps container.Patient removed vial that contained fluid (medication?) and syringe with needle attached.Patient hid these items, when nurse was taking items from the patient, the patient accidentally stuck the nurse with the needle.

• Brand Name: REHRIG PACIFIC
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): REHRIG PACIFIC COMPANY; 1000 raco court; lawrenceville GA 30046
• MDR Report Key: 5506844
• MDR Text Key: 40587355
• Report Number: 5506844
• Device Sequence Number: 1
• Product Code: MMK
• 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: Patient
• Type of Report: Initial
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TS (PATIENT ROOM)
• Is the Reporter a Health Professional?: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 26 YR