BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINOCAN®

    MDR report key: 18503960 · Received January 12, 2024

    Report

    Report Number
    9610825-2023-00685
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    November 3, 2023
    Report Date
    April 18, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MIA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). BBAJ INVESTIGATION RESULT 1. VISUAL INSPECTION THE COMPLAINT SAMPLE WAS NOT RETURNED. THE CONDITION OF COMPLAINT SAMPLE WAS CONFIRMED FROM THE PHOTO ATTACHED IN CC400634436. IT WAS OBSERVED THAT THE CANNULA OF COMPLAINT SAMPLE WAS TORN AT A POSITION APPROXIMATELY 70 MM FROM THE BASE OF HUB. 2. FUNCTIONAL TEST RESULT: NO ABNORMALITY <BENDING STIFFNESS TEST FOR RETENTION SAMPLES> BENDING STIFFNESS TEST WAS CONDUCTED ON THE RETENTION SAMPLE OF CANNULA PIPE IN ACCORDANCE WITH THE TESTING AND MEASURING METHOD NO.: IM-2011. THE TEST RESULTS MET OUR STANDARDS. OBJECTS TO BE MEASURED: PENCAN 27GX4 W.INTRO.-EU/AP (MAT NO. 4502124-13XX) (RETENTION SAMPLE) TARGET BATCH: 22N15H8B05 STANDARD: MAX 0.65MM (TEST CONDITION) SPAN: 7.5MM, TEST LOAD: 5.5N RESULT: (22N15H8B05) 0.288 MM EQUIPMENT (NO.): AUTOGRAPH (E-111) MEASURED BY: M. SUZUKI 3. OTHERS [VISUAL INSPECTION OF RETENTION SAMPLE] THERE WERE NO ABNORMALITIES SUCH AS BENT CANNULA ON THE APPEARANCE OF THE RETENTION SAMPLES (N=5PCS). 4. DEVICE HISTORY RECORD RESULT: NO ABNORMALITY ANY ABNORMALITY WAS NOT OBSERVED ON THE MANUFACTURING RECORDS OF PENCAN 27GX4 W.INTRO.-EU/AP (BATCH NO. 22N15H8B05). 5. DECISION AND JUSTIFICATION THIS COMPLAINT IS CONSIDERED AS NOT CONFIRMED. THE COMPLAINT SAMPLE HAD BEEN USED FOR A PROCEDURE, AND THERE WERE DEFORMATIONS IN ADDITION TO THE BROKEN PART. IT IS PRESUMED THAT THE CANNULA OF THE COMPLAINT SAMPLE WAS BENT AND TORN DURING THE PROCEDURE. ======================================================================== MATERIAL NO.: 4502124-13XX PRODUCT NAME: PENCAN 27GX4 W.INTRO.-EU/AP BATCH NO.: 22N15H8B05 ======================================================================== 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). 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. 1. VISUAL INSPECTION. THE COMPLAINT SAMPLE WAS NOT RETURNED. THE CONDITION OF COMPLAINT SAMPLE WAS CONFIRMED FROM THE PHOTO ATTACHED IN (B)(4). IT WAS OBSERVED THAT THE CANNULA OF COMPLAINT SAMPLE WAS TORN AT A POSITION APPROXIMATELY 70 MM FROM THE BASE OF HUB. 2. FUNCTIONAL TEST. RESULT: NO ABNORMALITY. BENDING STIFFNESS TEST WAS CONDUCTED ON THE RETENTION SAMPLE OF CANNULA PIPE IN ACCORDANCE WITH THE TESTING AND MEASURING METHOD NO.: IM-2011. THE TEST RESULTS MET OUR STANDARDS. 3. OTHERS. [VISUAL INSPECTION OF RETENTION SAMPLE]. THERE WERE NO ABNORMALITIES SUCH AS BENT CANNULA ON THE APPEARANCE OF THE RETENTION SAMPLES (N=5PCS). 4. DEVICE HISTORY RECORD. RESULT: NO ABNORMALITY. ANY ABNORMALITY WAS NOT OBSERVED ON THE MANUFACTURING RECORDS OF PENCAN 27GX4 W.INTRO.-EU/AP (BATCH NO. 22N15H8B05). 5. DECISION AND JUSTIFICATION. THIS COMPLAINT IS CONSIDERED AS NOT CONFIRMED. THE COMPLAINT SAMPLE HAD BEEN USED FOR A PROCEDURE, AND THERE WERE DEFORMATIONS IN ADDITION TO THE BROKEN PART. IT IS PRESUMED THAT THE CANNULA OF THE COMPLAINT SAMPLE WAS BENT AND TORN DURING THE PROCEDURE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN FRANCE: "NEEDLE BROKEN-DURING USE" ACCORDING TO THE COMPLAINANT DURING A SPINAL ANESTHETIC, THE NEEDLE BROKE WHEN IT WAS REMOVED FROM THE PATIENT. ONE PIECE REMAINED AND REQUIRED ADDITIONAL OPERATION TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2100541 SPINOCAN® SPINAL NEEDLE MIA B BRAUN MELSUNGEN AG 4502124-13 22N15H8B05

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention