BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN®

    MDR report key: 17121362 · Received June 13, 2023

    Report

    Report Number
    9610825-2023-00261
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    May 12, 2023
    Report Date
    September 18, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MIA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). WE RECEIVED ONE USED PENCAN 25GX3 1/2" (88MM)M.FK-EU/AP/SA WITHOUT PACKAGING. THE RECEIVED USED SAMPLE WAS TAKEN TO A VISUAL INSPECTION FOR DAMAGES ACCORDING TO THE TEST METHOD DAMAGES. THE USED PENCAN CANNULA IS BROKEN OFF AND BENT APPROX. 48 MM NEAR THE CANNULA HUB. THE AREA OF THE BREAK FROM THE RAW CANNULA SHOWS THAT THE CANNULA WAS BENT BEFORE THE BREAK. THERE IS ALSO A PRESSURE POINT IN THE CANNULA. AFTERWARDS, THE OUTSIDE DIAMETER OF THE PENCAN CANNULA WAS MEASURED ACCORDING TO DRAWING. NOMINAL-VALUE: 0.53 MM +0.01/-0 MM. ACTUAL VALUE: 0.53 MM. THE MEASURED VALUE (OUTSIDE DIAMETER) OF THE PENCAN CANNULA IS WITHIN THE SPECIFICATION. WE ASSUME OF A PROBLEM DURING THE APPLICATION PROCESS. BENDING STIFFNESS TEST HAS BEEN CONDUCTED ON THE RETENTION SAMPLE OF CANNULA TUBES. MATERIAL NO.: 4502043-13. BATCH NO.: 22M18H8B01. SPEC: MAX 0.43MM. RESULT: 0.310MM PASS. ANY ABNORMALITY IN THE HISTORY RECORD WAS NOT CONFIRMED. BASED ON THE CONDUCTED INVESTIGATIONS THE TESTED SAMPLE IS WITHIN THE SPECIFICATION. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED. 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 INTERNAL REPORT NUMBER: (B)(4). THE COMPLAINT IS UNDER INVESTIGATION. A FOLLOW-UP WILL BE PROVIDED AFTER THE INVESTIGATION RESULTS ARE AVAILABLE. 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 GERMANY: "NEEDLE BROKEN OFF." "NEEDLE BROKE OFF DURING SPA L3/4 (SECTIO), THE NEEDLE TIP (APPROX. 4CM LONG) REMAINED IN THE PATIENT'S BODY AND WAS SURGICALLY REMOVED FROM THE BACK MUSCLES. ALL MATERIAL HAS BEEN SECURED AND IS AVAILABLE. UNFORTUNATELY WE WERE UNABLE TO SALVAGE THE ORIGINAL PACKAGING OF THE BROKEN NEEDLE FROM THE WASTE, ATTACHED IS A PHOTO OF THE PACKAGING OF AN IDENTICAL NEEDLE FROM THE SAME ORDER. THE INCIDENT OCCURRED ON (B)(6) 2023 AT AROUND 08:39 ACCORDING TO THE OP PROTOCOL. AS THINGS STAND AT PRESENT, WE ARE UNABLE TO MAKE ANY STATEMENT ON THE PATIENT'S STATE OF HEALTH, AS SHE LEFT OUR PREMISES ON HER OWN RESPONSIBILITY ON (B)(6) 2023."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999327 PENCAN® SPINAL NEEDLE MIA B. BRAUN MELSUNGEN AG 22M18H8B01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention