FDA Adverse Event Injury Summary report: N

HAKIM PRECISION VALVE, STANDARD

MDR report key: 841516 · Received April 24, 2007

Report

Report Number: 1226348-2007-00114
Event Type: Injury
Date Received: April 24, 2007
Date of Event: March 25, 2007
Manufacturer: CODMAN & SHURTLEFF, INC./MEDOS S.A.
Product Code: JXG
PMA / PMN Number: K944222
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INVESTIGATION DID CONFIRM THE PROBLEM, A CRACK WAS NOTED IN THE SILICONE HOUSING NEAR THE VALVE OUTLET. THE SERIAL NUMBER OF THE VALVE WAS FOUND AND THE LOT NUMBER WAS CFMBRJ. THE PRODUCT CODE WAS 82-3003. THE LIKELY ROOT CAUSE OF THE CRACK NOTED IN THE SILICONE HOUSING WAS BELIEVED TO BE THAT THE VALVE HOUSING SUSTAINED SOME FORM OF MECHANICAL DAMAGE DURING THE IMPLANTATION PROCEDURE. A SMALL CUT OR A SHARP EDGE OF AN INSTRUMENT MAY HAVE BEEN THE CAUSE OF THE BEGINNING OF THE CRACK. HOWEVER, THIS COULD NOT BE CONFIRMED. NO CORRECTIVE ACTION IS NEEDED BASED ON THE RESULTS OF THE EVALUATION. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS.

Description of Event or Problem · 1

AFFILIATE REPORTED THAT THERE WAS AIR LEAKAGE FROM THE VALVE. IT WAS ALSO EXPLAINED THAT AS A RESULT, THE VALVE WAS REPLACED WITH A NEW ONE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT. SURGERY WAS DELAYED FOR MORE THAN THIRTY MINUTES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HAKIM PRECISION VALVE, STANDARD	CNS SHUNT	JXG	CODMAN & SHURTLEFF, INC./MEDOS S.A.	NA	CFMBRJ

Patients

Seq	Age	Sex	Outcome	Treatment
1	YR		Required Intervention