FDA Adverse Event Injury Summary report: N

HAKIM PERITON CATH,120CM

MDR report key: 12750910 · Received November 4, 2021

Report

Report Number: 3013886523-2021-00468
Event Type: Injury
Date Received: November 4, 2021
Date of Event: October 19, 2021
Report Date: January 19, 2022
Manufacturer: INTEGRA LIFESCIENCES SWITZERLAND SAR
Product Code: JXG
PMA / PMN Number: K944222
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE HAKIM PERITONEAL CATHETER (823045) WAS RETURNED FOR EVALUATION. NO ROOT CAUSE COULD BE DETERMINED AS NO DEFECT WAS REPORTED ON THE DEVICE, AS NOTED IN THE COMPLAINT INFORMATION: REMOVED DUE TO SHUNT OBSTRUCTION. AT THE TIME OF INVESTIGATION, NO CATHETER OCCLUSION WAS NOTED.

Description of Event or Problem · 0

N/A.

Additional Manufacturer Narrative · 1

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

3 OF 3 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2021-00466, 3013886523-2021-00467. A PHYSICIAN REPORTED THE CERTAS VALVE (ID 828804) WAS IMPLANTED INTO THE PATIENT VIA VENTRICULAR PERITONEAL SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THE VALVE WAS REMOVED AND REPLACED ON (B)(6) 2021, DUE TO THE POSSIBILITY OF SHUNT OBSTRUCTION. THE DEVICE WAS USED WITH 823041 (SERIAL;UNK) AND 823045 (SERIAL;UNK) WHICH WERE ALSO REMOVED. IT IS UNKNOWN THE CATHETER'S FAILURE OR IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS. IT IS ALSO UNKNOWN IF THE CATHETER WAS REPLACED AND HOW WAS THE PATIENT'S CURRENT CONDITION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1649402	HAKIM PERITON CATH,120CM	STANDARD CATHETERS	JXG	INTEGRA LIFESCIENCES SWITZERLAND SAR

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown