MAUDE Adverse Event Report: BACTISEAL EVD 1.9MM CATH SET; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-1749

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 03/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

During qa incoming goods inspection, the operator found that temperature monitor indicated temperature was out of range on product label.The temperature exceeded high limit (27c) on (b)(6) 2016.The temperature-indicating label didn't turn red.Now the goods are pending at warehouse.Please be advised if the goods need to be returned for investigation.

• Brand Name: BACTISEAL EVD 1.9MM CATH SET
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5580636
• MDR Text Key: 42771521
• Report Number: 1226348-2016-10303
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PK021653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-1749
• Device Lot Number: 724685
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 82-3074