MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. HAKIM PROGRAMMABLE VALVE WITHOUT PRECHAMBER; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3101

Device Problems Failure to Prime (1492); Failure to Pump (1502)

Patient Problem No Information (3190)

Event Date 03/18/2015

Event Type  malfunction  

Event Description

I need to report a complaint for item ns5489 lot number 618390.This item was opened on the backtable and was being prepared for an implant on 3/18 when the product would not prime.The chamber would not put pump.Can you please send a replacement item to deliver to the customer.It did not delay the customer more than 30 minutes and the doctor placed another valve in the patient.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Upon completion of the investigation it was noted that the valve is a precision valve with 4 dots.The valve was visually inspected; no defects were noted.The valve was irrigated with purified water.No occlusion was noted.The catheter was irrigated with purified water, no occlusion was noted.The valve was dried.The valve was leak tested.No leaks were noted.The valve was then pressure tested, the valve passed the test.The lot history record was reviewed for completeness during the release process to inventory.At that time based on the fact that no discrepancies were noted for the products being accepted, they were released to stock on the 19th august 2004.No root cause could be determined as the problem reported by the customer could not be duplicated.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: HAKIM PROGRAMMABLE VALVE WITHOUT PRECHAMBER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 4647651
• MDR Text Key: 20119959
• Report Number: 1226348-2015-10205
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK974739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2009
• Device Catalogue Number: 82-3101
• Device Lot Number: CRDBG5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2004
• 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