BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN®

    MDR report key: 20591657 · Received November 1, 2024

    Report

    Report Number
    9610825-2024-00785
    Event Type
    Injury
    Date Received
    November 1, 2024
    Date of Event
    September 19, 2024
    Report Date
    December 2, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    OFU
    UDI-DI
    04046964180798
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION 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). 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 INFORMATION D9 DEVICE RETURNED TO MANUFACTURER. VISUAL INSPECTION SINCE THE SAMPLE OF THE COMPLAINT ITEM WAS NOT RETURNED, WE CONFIRMED THE NEEDLE BREAKAGE ISSUE FROM THE PHOTO OF THE COMPLAINT ITEM ATTACHED TO CC/IC NOTIFICATION NO. (B)(4). A PART OF THE BROKEN PENCAN CANNULA WAS VISIBLE IN THE PHOTO. THERE WERE NO ABNORMALITIES IN THE APPEARANCE OF THE RETENTION SAMPLE. FUNCTIONAL TEST RESULT: NO ABNORMALITY STIFFNESS TEST OF CANNULA THE TEST RESULT WERE WITHIN THE SPECIFICATION. HISTORY REVIEW RESULT: NO ABNORMALITY THERE WERE NO ABNORMALITIES IN THE MANUFACTURING RECORDS. DECISION AND JUSTIFICATION THIS COMPLAINT IS CONSIDERED AS NOT CONFIRMED. NO ABNORMALITIES WERE FOUND IN THE INVESTIGATION RESULTS. MATERIAL NO.: (B)(4). PRODUCT NAME: (B)(4). BATCH NO.:(B)(4). BBM INVESTIGATION REPORT FROM 2024-11-11. WE RECEIVED ONE USED PENCAN 25GX4" (103MM) M. FK-EU/AP/SA IN OPEN PACKAGING AND 15 SAMPLES IN ORIGINAL PACKAGING. VISUAL INSPECTION: THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL INSPECTION FOR DAMAGES ACCORDING TO THE TEST METHOD 102002_DAMAGES. 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: ON THE CANNULA THAT WAS HANDED OVER, THE CANNULA BROKE OFF DIRECTLY AT THE CANNULA HUB (SEE PICTURE 4 - 6). FURTHERMORE, THE CANNULA IS BROKEN OFF IN THE AREA APPROXIMATELY 53 MM FROM THE CANNULA HUB AND STRONGLY KINKED IN THE AREA APPROX. 46 MM FROM THE CANNULA HUB. THE CANNULA WAS BENT REPEATEDLY AT BOTH AREAS OF THE FRACTURES AND IN THE AREA OF THE KINK AND THIS CAUSED THE CRACKS OF THE CANNULA. WE ASSUME THAT PROBLEMS OCCURRED DURING USE, CAUSING THE CANNULA TO BE BENT SEVERAL TIMES AND FINALLY BREAK. AT THE ORIGINAL PACKAGED SAMPLES NO DAMAGES OR OTHER DEVIATIONS WE COULD DETECT. PHYSICAL INSPECTION: NOMINAL: LENGTH OF THE CANNULA MUST BE 108,9 ± 0,5 MM ACCORDING TO DRAWING. ACTUAL: LENGTH OF THE RECEIVED CANNULA APPROX. 46 MM AND APPROX. 7 MM OVERALL APPROX. 53 MM. THIS MEANS APPROX. 55,9 MM BE MISSING. THIS PART (APPROX. 55.9 MM FROM THE CANNULA TIP) OF THE CANNULA WAS NOT HANDED OVER BY CUSTOMER. NOMINAL: OUTER DIAMETER Ø 0,53 MM +0,01 / -0 MM ACCORDING TO DRAWING. ACTUAL: OUTER DIAMETER Ø 0,53 MM. SUMMARY AND ASSESSMENT: RELATING TO THE DAMAGED SAMPLE WE ASSUME OF A PROBLEM DURING THE APPLICATION PROCESS. BASED ON THE CONDUCTED INVESTIGATIONS THE TESTED SAMPLE IS WITHIN THE SPECIFICATION. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION THERE WAS AN ACCIDENTAL AND UNPREDICTABLE BREAKAGE OF A SPINAL NEEDLE WITH RETENTION OF ITS DISTAL END IN THE SUBCUTIS. REPORTEDLY THERE WAS AN INTERVENTION TO REMOVE DISTAL PART IN THE SUBCUTIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2188170 PENCAN® SPINAL ANESTHESIA KIT OFU B BRAUN MELSUNGEN AG 4502116-13 23M20H8B02 04046964180798

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Unknown Required Intervention