BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PERITON CATH,120CM

    MDR report key: 15501775 · Received September 29, 2022

    Report

    Report Number
    3013886523-2022-00446
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    September 12, 2022
    Report Date
    December 5, 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

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

    Additional Manufacturer Narrative · 0

    THE HAKIM PERITONEAL CATHETER (ID (B)(4) WAS RETURNED FOR EVALUATION. FAILURE ANALYSIS - ONLY 5MM OF CATHETER WAS RETURNED STILL ATTACHED TO THE CONNECTOR, IMPOSSIBLE TO INVESTIGATE. NO INVESTIGATION IS NEEDED AS "THE SALES REP INFORMED THAT THERE WAS NO PROBLEM WITH THE CATHETER AND THAT AN INVESTIGATION WAS UNNECESSARY¿. NO ROOT CAUSE IS NEEDED "THE SALES REP INFORMED US THAT THERE WAS NO PROBLEM WITH THE CATHETER AND THAT AN INVESTIGATION WAS UNNECESSARY¿.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: THERE WAS NO DEFECT IN HAKIM PERITONEAL CATHETER (ID 823045); HOWEVER, IT WAS REMOVED AND REPLACED.

    Description of Event or Problem · 0

    THIS IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00445. A PHYSICIAN REPORTED A CERTAS VALVE (ID (B)(4)) WAS IMPLANTED VIA L-P SHUNT 5 YEARS AGO (UNKNOWN DATE) WITH UNKNOWN SETTING. THE VALVE WAS PLACED WITH (B)(4) (LOT#; UNK) AND THE SILASCON LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). ON (B)(6) 2022, THE PATIENT HAD SEVERE HEADACHE AND THE SETTING WAS CHANGED FROM 3 TO LOW, HOWEVER, THE SETTING COULD NOT BE CHANGED. ON (B)(6) 2022, THEY TRIED TO CHANGE THE SETTING AGAIN, BUT IT WAS NOT POSSIBLE. THEREFORE, THE VALVE AND HAKIM PERITONEAL CATHETER (ID (B)(4)) WERE REMOVED AND REPLACED. PHYSICIAN ALSO SUSPECTED THE VALVE AND CATHETER¿S OCCLUSION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2929962 HAKIM PERITON CATH,120CM STANDARD CATHETERS JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Female