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

Catalog Number S420GH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/18/2014

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 evaluation: one used device returned for evaluation.The evaluation is in process.A follow up report will be submitted when the evaluation has been 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 ; parc de nations, paris; paris nord 2 383 rue de la belle; etoile roissy ch de gaulle cede ; FR ; 148172529
• MDR Report Key: 3855793
• MDR Text Key: 4682619
• Report Number: 9615728-2014-00002
• 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: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: S420GH
• Device Lot Number: X570815-5
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/20/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2013
• 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