MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM IN LINE PROGRAMMABLE VALVE; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3164

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Information (3190)

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The sales rep reported "customer reported that when testing the valve the fluid just ran off did not stop.The valve did not appear to function properly.This occurred while testing valve in the or - used a backup valve.No patient injury or delay in surgery reported as a result of this incident.

Manufacturer Narrative

Upon completion of the investigation it was noted that the position of the cam when valve was received was 40mmh2o.The valve was visually inspected, a clear liquid was noted inside the valve, and no defects were noted.The valve 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 reflux tested, the valve passed the test.The valve was tested for programming.The valve passed the test.The valve was then pressure tested, the valve passed the test.Review of the history device records confirmed the valve product code 82-3164 with lot crcc1c, conformed to the specifications when released to stock in 14th april 2014.No root cause could be determined as the valve functioned.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 IN LINE PROGRAMMABLE VALVE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5221405
• MDR Text Key: 31076963
• Report Number: 1226348-2015-10671
• 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: 11/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 82-3164
• Device Lot Number: CRCCIC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2014
• 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