MAUDE Adverse Event Report: GENZYME SYNVISC ONE 6CC

Lot Number 4RSF014

Device Problems Disconnection (1171); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2015

Event Type  malfunction  

Event Description

During intra-articular knee injection of synvisc one, the plastic adapter between the syringe and needle that is pre-assembled by the manufacturer became disconnected (it is not supposed to be able to come apart) resulting in leakage of synvisc from the syringe as opposed to intra-articular injection.Injection was stopped at this point and the syringe and adapter were removed, leaving the needle in place in the knee.A new syringe of synvisc one was opened and attached to the needle and the new medication was injected without further complication.Sterile technique was able to be maintained and there was no apparent harm to the patient.Diagnosis or reason for use: osteoarthritis knee.

• Brand Name: SYNVISC ONE 6CC
• Type of Device: SYNVISC ONE 6CC
• Manufacturer (Section D): GENZYME
• MDR Report Key: 5061671
• MDR Text Key: 25315320
• Report Number: MW5056021
• Device Sequence Number: 1
• Product Code: MOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Report Date: 09/02/2015

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: 09/30/2017
• Device Lot Number: 4RSF014
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 92 YR