BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOJECT NEEDLE

    MDR report key: 7600788 · Received June 14, 2018

    Report

    Report Number
    3004827015-2018-00001
    Event Type
    Injury
    Date Received
    June 14, 2018
    Date of Event
    May 17, 2018
    Report Date
    August 3, 2018
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    IKT
    PMA / PMN Number
    K002992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD REQUESTED. CUSTOMER RETURNED THE CABLE THAT WAS ATTACHED TO THE NEEDLE AND THE PACKAGING OF THE NEEDLE USED. THE NEEDLE ITSELF WAS NOT RETURNED AS NO SURGICAL INTERVENTION HAS BEEN CARRIED OUT TO REMOVE THIS NEEDLE FORM THE PATIENT. NO FURTHER INVESTIGATION CAN BE CARRIED OUT ON THE DEFECT PART. UPDATE FROM THE DOCTOR IN RELATION TO THE PATIENT OUTCOME ON THE 01ST AUGUST 2018: THE LAST CONSULTATION DATE ABOUT TWO WEEKS, NO DISCOMFORT FOR THE PATIENT, NO SIGN OF INFECTION EITHER AT THE LEVEL OF THE PATIENT. NEEDLE (RADIOS OK), NO PLANNED REMOVAL OF THE NEEDLE FOLLOWING SURGICAL ADVICE. SO FAR NO PATIENT CONSEQUENCES REPORTED FOR THIS PATIENT. RISK REVIEW COMPLETED: DOC-012710 RISK ANALYSIS AND RISK MANAGEMENT REPORT - DANTEC DISPOSABLE NEEDLE ELECTRODES REV C WAS REVIEWED. THERE ARE TWO POTENTIAL HAZARDS AND HAZARDOUS SITUATIONS ASSOCIATED WITH COMPLAINT, ID 20 (LOSS OF MECHANICAL INTEGRITY) AND 25 (PHYSICAL INJURY - NEEDLE BREAK). THE OVERALL RISK RATING FOR ID 20 IS 3B (SEVERITY OF HAZARD - 3- MODERATE, PROBABILITY OF HAZARD - B - REMOTE). THE OVERALL RISK RATING FOR ID 25 IS 3A (SEVERITY OF HAZARD - 3- MODERATE, PROBABILITY OF HAZARD - A - UNLIKELY). THE COMPLAINT LOG WAS REVIEWED OVER THE PAST 12 MONTHS. NO SIMILAR COMPLAINT RECEIVED IN THE PAST 12 MONTHS. 1 SIMILAR COMPLAINT FOR THIS PART RECEIVED IN FEBRUARY 2017. NO TREND HAS BEEN OBSERVED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS CURRENTLY ONGOING INTO THE REPORTED ISSUE. FURTHER INFORMATION HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S PRELIMINARY ANALYSIS: DEVICE HISTORY RECORD (DHR) REQUESTED, THE DHR WILL BE REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT. COMPONENTS OF THE NEEDLE REQUESTED TO BE RETURNED. MEDICAL DEVICE IS NOT IMPLANTABLE. MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. DEVICE MANUFACTURE DATE: THE DHR HAS BEEN REQUESTED, EXPIRATION DATE WILL BE OBTAINED FROM THIS RECORD.

    Description of Event or Problem · 1

    DURING THE INJECTION OF BOTULINUM TOXIN INTO THE POSTERIOR TIBIALIS MUSCLE FOR AN OBESE SPASTIC HEMIPLEGIC PATIENT, A NEEDLE 9013S0442 (LOT: N-2017-06-010) WAS TWISTED AND BROKEN AT ITS JUNCTION WITH ITS SUPPORT. CLINICAL CONSEQUENCES AND CURRENT STATUS OF THE PATIENT: THE NEEDLE REMAINED IN THE POSTERIOR TIBIALIS MUSCLE OF THE PATIENT. ACTION FROM THE CUSTOMER FOR THE PATIENT: RADIOLOGICAL AND CLINICAL MONITORING, NO SURGICAL INTERVENTION DECIDED AT THE MOMENT. ACTION FROM THE CUSTOMER: NO RECALL OF THE PRODUCT, REPORT SENT TO (B)(6) BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444835 BOJECT NEEDLE BOJECT DISPOSABLE HYPODERMIC NEEDLE IKT NATUS MANUFACTURING LIMITED 9013S0442 N-2017-06-010

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other