MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA EMBOSPHERES MICROSPHERES

Catalog Number S410GH-003/A

Device Problems Failure to Deliver (2338); Failure to Infuse (2340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

The suspect device will be returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that there is black foreign matter in the microspheres.This was not sold to the hospital and there was no harm to any patients.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: EMBOSPHERES MICROSPHERES
• Type of Device: MICROSPHERES
• Manufacturer (Section D): BIOSPHERE MEDICAL SA; parc des nations, paris nord 2; 383, rue de la belle etoile; 95700 ; FR 95700
• MDR Report Key: 9501069
• MDR Text Key: 196218802
• Report Number: 9615728-2019-00014
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• PMA/PMN Number: K021397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: S410GH-003/A
• Device Lot Number: X1549918
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1