MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM PROG VALVE INLINE SIPHONGUARD; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3842

Device Problem Device Issue (2379)

Patient Problem No Information (3190)

Event Date 10/23/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Valve malfunction after mrt procedure.

Manufacturer Narrative

Upon completion of the investigation, it was noted that the valve was visually inspected it was noted that the stator and x ray dot were dislodged.Therefore; the cam position/pressure could not be determined.The valve was dismantled and was examined under microscope at appropriate magnification: no damage to the valve casing was noted.Corrosion on the edge of the stator and x ray dot was observed.Review of the history device records confirmed the valve product code 82-3842, with lot ckkccz, conformed to the specifications when released to stock on the 15th september 2009.The root cause of the stator and x ray dot dislodgement could not be clearly determined.Investigation for the corrosion issue on hakim valves is being followed with capa.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 PROG VALVE INLINE SIPHONGUARD
• 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: 5237731
• MDR Text Key: 31671030
• Report Number: 1226348-2015-10686
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK992173
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2014
• Device Catalogue Number: 82-3842
• Device Lot Number: CKKCCZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2009
• 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
• Patient Outcome(s): Required Intervention