BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERICAN®

    MDR report key: 16705055 · Received April 8, 2023

    Report

    Report Number
    9610825-2023-00133
    Event Type
    Injury
    Date Received
    April 8, 2023
    Date of Event
    February 24, 2023
    Report Date
    August 31, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE INVESTIGATION DID NOT CONFIRM ANY MALFUNCTIONS OR DETERIORATION IN THE CHARACTERISTICS OR PERFORMANCE OF A DEVICE. THE RETURNED SAMPLE WAS TAKEN TO A VISUAL EXAMINATION. THE NEEDLE WAS BROKEN FROM HUB AND GLUE CONE IS SUFFICIENT ON THE CANNULA HUB JOINT AREA. REFERENCED SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR NEEDLE HUB TO CANNULA DETACHMENT TEST AND THE RESULT FOUND WITHIN THE SPECIFICATION. IN THE EVENT OF THE NEEDLE OR SYRINGE IS MOVED OR SLANTED DURING THE PROCEDURE, THERE'S A TENDENCY FOR THE NEEDLE TO BECOME BENT AND SUBSEQUENT CONTACT AND FORCE EXERTED COULD LEAD TO CANNULA BREAKAGE. THE BATCH RECORD REVIEW DOES NOT SHOW ANY DEVIATIONS THAT MIGHT BE RELATED TO THE REPORTED FAILURE. THE DESCRIBED EVENT WAS CAUSED BY AN USE ERROR. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED, AS SOON AS INVESTIGATION HAS BEEN COMPLETED. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN SINGAPORE. ACCORDING TO THE CUSTOMER: "STERICAN G30 DETACHMENT." "PATIENT 24YO/MALE SAW DOCTOR FOR REMOVAL OF CYST ON THE UPPER BACK. UPON REMOVAL OF THE SYRINGE-NEEDLE AFTER ADMINISTERING LOCAL ANAESTHESIA (LIGNOCAINE), HE DISCOVERED THAT NEEDLE WAS DETACHED FROM THE HUB AND EMBEDDED ON THE PATIENT. THE DOCTOR ATTEMPTED TO REMOVE THE NEEDLE BUT WAS UNABLE TO. HE SENT THE PATIENT FOR ULTRASOUND AND X'RAY, WHICH REVEALED THE NEEDLE TO BE 4MM BENEATH AND PARALLEL TO THE SKIN. PATIENT WAS SUBSEQUENTLY REFERRED TO SURGEON FOR SURGICAL REMOVAL OF THE NEEDLE, SCHEDULED FOR (B)(6) 2023. THE PATIENT IS FILING A CLAIM AGAINST THE DOCTOR, WHO HAS REFERRED THE CASE TO HIS INSURANCE COMPANY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440707 STERICAN® STANDARD HYPODERMIC NEEDLES FMI B. BRAUN MELSUNGEN AG 21K29G8812

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown