MAUDE Adverse Event Report: COOPERSURGICAL, INC. SERUM PROTEIN SUB,12X12ML

Model Number ART-3010

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

Report as per request from fda medwatch program "this is to bring to your attention that we are in receipt of several supplement reports submitted by coopersurgical, inc., please be informed that there is no record of initial report submissions in emdr system.It appears that follow-up #1 could be actual initial report but may have been erroneously submitted as follow-up in error.Kindly verify the supplement reports listed below and resubmit follow-up #1 report as initial report electronically through esg webtrader by checking only "initial" box and advise when complete.".

Event Description

"when opened the bottle of art-3010, some abnormal microbial were found." "after culture in the incubator, the abnormal microbial were increased." ref e-complaint (b)(4).

• Brand Name: SERUM PROTEIN SUB,12X12ML
• Type of Device: SERUM PROTEIN SUB,12X12ML
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC,; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 5922426
• MDR Text Key: 225123974
• Report Number: 1216677-2016-00020
• Device Sequence Number: 1
• Product Code: MQL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K003734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2016

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 Expiration Date: 07/26/2017
• Device Model Number: ART-3010
• Device Catalogue Number: ART-3010
• Device Lot Number: F210A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2016
• Initial Date FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other