MAUDE Adverse Event Report: AMGEN USA, INC. PROLIA; SYRINGE, PISTON

Model Number 00355513710015

Device Problem Device Slipped (1584)

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

Event Date 06/08/2020

Event Type  malfunction  

Event Description

Single dose pre-filled syringe fell out of outer retractable, safety device.

• Brand Name: PROLIA
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): AMGEN USA, INC.; 12000 plantside dr; louisville KY 40299
• MDR Report Key: 10641624
• MDR Text Key: 210230084
• Report Number: 10641624
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00355513710015
• Device Lot Number: 1113279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Weight: 49