MAUDE Adverse Event Report: BIOSPHERE MEDICAL, S.A. EMBOSPHERE MICROSPHERES

Model Number S220GH

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

Patient Problem No Patient Involvement (2645)

Event Date 12/19/2014

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 the received products.The device was not sent to a user facility.

Manufacturer Narrative

Device returned to manufacturer for evaluation.The evaluation is in process.A follow-up report will be submitted when the evaluation is completed.

• Brand Name: EMBOSPHERE MICROSPHERES
• Manufacturer (Section D): BIOSPHERE MEDICAL, S.A.; rpossu-en-francre ; FR
• Manufacturer (Section G): BIOSPHERE MEDICAL, S.A.; bat.a.parc de nations, paris; nord 2 383 rue de la belle; etolle rossy ch de gaulle cede ; FR
• Manufacturer Contact: alix fonlladosa ; parc des nations- paris; nord 2 383 rue de la belle; etolle rossy ch de gaulle cede 95 70-0 ; FR 95 700 ; 48172529
• MDR Report Key: 4638883
• MDR Text Key: 5575589
• Report Number: 9615728-2015-00004
• 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: Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: S220GH
• Device Catalogue Number: S220GH
• Device Lot Number: X723999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/02/2015
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2014
• 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