HAKIM INLINE PROGRAMMABLE VALVE SG

MDR report key: 5363151 · Received January 13, 2016

Report

Report Number: 1226348-2016-10048
Event Type: Injury
Date Received: January 13, 2016
Date of Event: December 21, 2015
Manufacturer: CODMAN & SHURTLEFF, INC. / MEDOS S.A.
Product Code: JXG
PMA / PMN Number: PK992173
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 70MMH2O. THE INNER BLISTER WAS OPENED TO SEE THE SERIAL NUMBER ON THE VALVE. (B)(4), THE PRODUCT CODE WAS CONFIRMED WITH THE SERIAL NUMBER PRODUCT CODE (B)(4). REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3162, WITH (B)(4), CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 11TH SEPTEMBER 2015. 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.

Description of Event or Problem · 1

THE SALES REP REPORTED THAT THE CLINICIAN WHEN THEY OPENED THE VALVE PACKAGE, THE VALVE WAS NOT A 82-3162 AS STATED IN THE PACKAGING. DR. CLAIMS THE WRONG VALVE WAS IN THE PACKAGE. APPEARANCE IS DIFFERENT THEN VALVE 82-3162. NO PATIENT HARM OR DELAY IN SURGERY REPORTED, NOTED BEFORE CASE. USED OTHER VALVE TO COMPLETE CASE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
21808	HAKIM INLINE PROGRAMMABLE VALVE SG	SHUNT, CENTRAL NERVOUS SYSTEM & COMPS	JXG	CODMAN & SHURTLEFF, INC. / MEDOS S.A.		CTHCNF

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention