BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN®

    MDR report key: 16761905 · Received April 18, 2023

    Report

    Report Number
    9610825-2023-00108
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    February 8, 2023
    Report Date
    November 14, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MIA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). WE RECEIVED ONE BROKEN OFF PART OF A USED PENCAN 27GX4" (103MM) M. FK-EU/AP/SA WITHOUT PACKAGING AND TWO PICTURES OF AN OPTICAL UNUSED PENCAN 27GX4" (103MM) M. FK-EU/AP/SA WITH PACKAGING. THE FOLLOWING INVESTIGATIONS WERE CONDUCTED: VISUAL INSPECTION: THE SAMPLE AND THE RECEIVED PICTURES WERE TAKEN TO A VISUAL INSPECTION FOR DAMAGES ACCORDING TO THE TEST METHOD. DEFINITION OF THE METHOD: DAMAGES ARE VISIBLE CHANGES IN THE ORIGINAL SHAPE OR SURFACE OF PRODUCTS AND PACKAGING CAUSED BY MECHANICAL FORCES AND/OR MANUFACTURING FAULTS. NOMINAL: NO DAMAGE IS ALLOWED THAT ENDANGERS THE PATIENT, IMPEDES THE USE OF THE PART AS INTENDED (E.G. THE IMPAIRMENT OF THE FUNCTION OF A DROP SENSOR), ENDANGERS THE ASSEMBLY OR FUNCTION OF THE COMPONENT, IMPAIRS THE APPEARANCE OF THE COMPONENT. ACTUAL: DAMAGES OR OTHER DEVIATIONS WERE NOT DETECTED AT THE SAMPLE FROM THE PICTURE. AT THE RECEIVED SAMPLE WE DETECTED THAT THE PENCAN 27GX4" (103MM) M. FK-EU/AP/SA IS BROKEN OFF. WE ONLY RECEIVED THE SEGMENT WITH THE TIP. THE PENCAN 27GX4" (103MM) M. FK-EU/AP/SA IS CROOKED AND BENT. THE AREA OF THE BREAK ON THE RAW CANNULA SHOWS THAT THE CANNULA WAS BENT BEFORE THE BREAK. PHYSICAL INSPECTION: AFTERWARDS, THE OUTSIDE DIAMETER OF THE PENCAN 27GX4" (103MM) M. FK-EU/AP/SA (SEVERAL AREAS) WAS MEASURED ACCORDING TO DRAWING. NOMINAL-VALUE: 0.42 MM +0.01/-0 MM. ACTUAL VALUE: 0.42 MM. THE MEASURED VALUE (OUTSIDE DIAMETER) OF THE PENCAN 27GX4" (103MM) M. FK-EU/AP/SA IS WITHIN THE SPECIFICATION. SUMMARY AND ASSESSMENT: BECAUSE THE MEASURED VALUE IS WITHIN THE SPECIFICATION AND THE SAMPLE WAS ALREADY USED, WE ASSUME OF A PROBLEM DURING THE HANDLING PROCESS. BASED ON THE CONDUCTED INVESTIGATIONS THE TESTED SAMPLE IS WITHIN THE SPECIFICATION. WE CONDUCTED RELEVANT TEST FOR RETENTION SAMPLE. VISUAL: ANY ABNORMALITY WAS NOT FOUND. STIFFNESS TEST: TEST METHOD: IM-2011, MAT:4502124-13XX, BATCH:22H09H8B05, TEST SPEC: MAX 0.65MM, TEST RESULT: 0.284MM, JUDGED: WITHIN SPECIFICATION, TEST SPAN:7.5MM, TEST LOAD:5.5N. DEVICE HISTORY RECORD: ANY ABNORMALITY WAS NOT FOUND. CONCLUSION: THIS COMPLAINT WAS NOT CONFIRMED. MAT:4502124-13XX. BATCH:22H09H8B05. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN BELGIUM) "NEEDLE BROKE DURING INTERVENTION." ACCORDING TO THE CUSTOMER: "WHEN PUNCTURING WITH PENCAN 4502124-13, THE NEEDLE WAS FOUND TO BE TOO SHORT TO REACH THE SPINAL SPACE. UPON EXTRACTING THE NEEDLE WITH THE INTRODUCER, THE DOCTOR FELT A CLICK AND FOUND ABOUT 5 CENTIMETRES OF THE NEEDLE MISSING. A CT LWZ WAS THEN PERFORMED AND AFTER NEUROSURGICAL ADVICE, IT WAS DECIDED TO SURGICALLY REMOVE THE NEEDLE. THE PIECE OF BROKEN OFF NEEDLE WAS DELIVERED TO THE BUYING DEPT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092056 PENCAN® SPINAL NEEDLE MIA B. BRAUN MELSUNGEN AG 22H09H8B05

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention