MAUDE Adverse Event Report: BIOSPHERE MEDICAL, S.A. EMBOSPHERE MICROSPHERES; AGENTS, EMBOLIC, FOR TREATMENT OF UF

Model Number S620GH

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 11/26/2014

Event Type  malfunction  

Event Description

The distributor reported that a fiber/hair was identified in the barrel of the syringe during their 100% inspection of received product.The device was not sent to a user facility.

Manufacturer Narrative

Device returned to mfr for eval.The eval is in progress.A f/u report will be submitted when the eval is completed.

• Brand Name: EMBOSPHERE MICROSPHERES
• Type of Device: AGENTS, EMBOLIC, FOR TREATMENT OF UF
• Manufacturer (Section D): BIOSPHERE MEDICAL, S.A.; roissy-en-france ; FR
• Manufacturer Contact: alix fonlladosa ; 383, rue de la belle etoile; parc des nations - paris nord 2; roissy en france 95 70-0 ; FR 95 700 ; 4817252
• MDR Report Key: 4479671
• MDR Text Key: 5347759
• Report Number: 9615728-2015-00002
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: S620GH
• Device Catalogue Number: S620G
• Device Lot Number: X710163
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/30/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1