MAUDE Adverse Event Report: GENZYME SYNVISC ONE HYLAN GF 20

Device Problem Application Program Problem: Medication Error (3198)

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

Event Date 02/25/2016

Event Type  malfunction  

Event Description

Patient had hyalgan sodium hyaluronate 20mg/2ml ordered (fidia pharma mfr) injection for series of 3 weekly injections.Pharmacy accidentally dispensed synvisc one hylan fg 20 (genzyme mfr).Clinic nurse noticed dispensing error before administered to patient.Near miss due to product labeling similarities.Errors due to product labeling similarities.Hyalgan sodium hyaluronate 20mg/ml and synvisc one hylan gf 20.A #1 dose or amount: 20mg syringe ordered; frequency: weekly x3; route: intra articular.A #2 dose or amount: 48mg syringe almost administer; frequency: once; route: intra articular.Diagnosis or reason for use: #1 arthritis.Is the product compounded? no.Is the product over-the-counter? no.

• Brand Name: SYNVISC ONE HYLAN GF 20
• Type of Device: SYNVISC ONE HYLAN GF 20
• Manufacturer (Section D): GENZYME
• MDR Report Key: 5707011
• MDR Text Key: 46875753
• Report Number: MW5062728
• Device Sequence Number: 2
• Product Code: MOZ
• UDI-Device Identifier: 5846800903
• UDI-Public: 58468-0090-3
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/06/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 98