MAUDE Adverse Event Report: GENZYME SYNVISC ONE 48MG/6ML

Lot Number 6RSL014

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 08/24/2016

Event Type  malfunction  

Event Description

Physician was administering injection and noticed that the solution began leaking from around the luer site luer-lok had become separated from the syringe.Needle had separated from syringe and needle remained in the pt's leg.Physician withdrew the needle from the pt's leg and administered with a syringe and needle.Dose or amount: 6 ml millilitre(s) frequency: other, route: intra-articular, therapy date start date: (b)(6) 2016, therapy end date: (b)(6) 2016.Diagnosis or reason for use: osteoarthritis.Expiration date: march 31, 2019.Event abated after use stopped or dose reduced: yes.Event reappeared after reintroduction: no.

• Brand Name: SYNVISC ONE 48MG/6ML
• Type of Device: SYNVISC ONE 48MG/6ML
• Manufacturer (Section D): GENZYME
• MDR Report Key: 6016604
• MDR Text Key: 57252592
• Report Number: MW5065256
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 58468009003
• UDI-Public: 58468-0090-03
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2016

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: 03/31/2019
• Device Lot Number: 6RSL014
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 77