MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. HAKIM PROGRAMMABLE VALVE, RT ANGLE W/SIPHONGUARD; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3182

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been returned for evaluation.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the affiliate, the surgeon believes a hakim programmable valve is broken because water can flow quickly without being stopped by the valve.Another was used to complete the procedure.There were no reports of delay or patient harm.

Manufacturer Narrative

(b)(4).The device was returned for evaluation.The valve was visually inspected: no defects were noted.The valve was tested for programming and passed.The valve was flushed; no occlusion was noted.The valve was leak tested and passed.The valve was reflux tested and passed.The siphon guard was tested and passed.The siphon guard was removed.The valve was then pressure tested and passed.A review of manufacturing records found that the device conformed to specification when released to stock.Based on the results of the investigation, the reported issue could not be confirmed.The device functioned as intended.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: HAKIM PROGRAMMABLE VALVE, RT ANGLE W/SIPHONGUARD
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC.; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: karen anigbo ; 11 cabot boulevard; mansfield, MA 02048 ; 7819715608
• MDR Report Key: 8010894
• MDR Text Key: 125287275
• Report Number: 1226348-2018-10766
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 82-3182
• Device Lot Number: 197228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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