BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN®

    MDR report key: 20907110 · Received December 11, 2024

    Report

    Report Number
    9610825-2024-00903
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    October 28, 2024
    Report Date
    December 11, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    BSP
    UDI-DI
    04046964180989
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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). 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. HC-PM COMPLAINT PROCESSING RECEIVED NO SAMPLE, WE RECEIVED ONE CUSTOMER PICTURE OF THE COMPLAINED AND USED PENCAN 27GX3 1/2" (88MM) M. FK-EU/AP/SA. THE FOLLOWING INVESTIGATIONS WERE CONDUCTED: VISUAL INSPECTION: THE RECEIVED PICTURE WAS TAKEN TO A VISUAL INSPECTION ACCORDING 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: THE RECEIVED PICTURE SHOWS 3 USED PENCAN 27GX3 1/2" (88MM) M. FK-EU/AP/SA AND A SYRINGE. AT THE COMPLAINED AND USED PENCAN 27GX3 1/2" (88MM) M. FK-EU/AP/SA A PART OF THE NEEDLE IS BROKEN OFF. THE BROKEN OFF PART IS NOT BEND. WEAK POINTS IN THE MATERIAL WHICH LEAD TO A BREAK OF THE CANNULA WERE NOT DETECTED BASED ON THE PICTURES. AT THE OTHER TWO PENCAN 27GX3 1/2" (88MM) M. FK-EU/AP/SA NO DAMAGES WERE DETECTED. FUNCTIONAL INSPECTION: N.A. PHYSICAL INSPECTION: N.A. SUMMARY AND ASSESSMENT: RELATING TO THE BROKEN OFF PART OF ONE PENCAN NEEDLE, WE ASSUME OF A PROBLEM DURING THE APPLICATION PROCESS. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED. HOWEVER, IF THE COMPLAINT SAMPLE WILL BE PROVIDED, THE COMPLAINT WILL BE RE-OPENED ACCORDINGLY. THE INVESTIGATION SAMPLE(S) IS/ARE NOT AVAILABLE. BBAJ INVESTIGATION RESULT: 1. VISUAL INSPECTION [CONFIRMATION OF THE COMPLAINT SYMPTOMS]: BECAUSE THE COMPLAINT SAMPLE WAS NOT RETURNED, WE CONFIRMED THE COMPLAINT FROM THE PHOTO OF THE PRODUCT ATTACHED TO CASE NO. (B)(4). ACCORDING TO THE PHOTO, IT WAS CONFIRMED THAT THE PENCAN 27GX3 1/2 W.INTRO.-EU WAS BROKEN NEAR THE CENTER OF THE EFFECTIVE PUNCTURE LENGTH. ACCORDING TO THE CUSTOMER INFORMATION, THE BREAK LENGTH WAS 40MM. THE CAUSE OF THE CANNULA NEEDLE'S BREAKAGE COULD NOT BE IDENTIFIED FROM THE PROVIDED PHOTO. [VISUAL INSPECTION OF RETENTION SAMPLES]: BECAUSE THE COMPLAINT ITEM WAS NOT RETURNED, WE CHECKED THE RETENTION SAMPLE OF PENCAN 27GX3 1/2 W.INTRO.-EU OF THE SAME BATCH NUMBER. THERE WERE NO ABNORMALITIES IN THE APPEARANCE OF THE RETENTION SAMPLE. OK: 5/5PCS. 2. FUNCTIONAL TEST: RESULT: NO ABNORMALITY, [STIFFNESS TEST] (TEST MEASUREMENT METHOD IM-2011), MEASURED THE STRENGTH OF CANNULA PIPE. INVESTIGATION TARGET (RETENTION SAMPLE), PENCAN 27GX3 1/2 W.INTRO.-EU, MAT. NO. 4502051-13XX, BATCH NO. 23D24H8B01. 3. HISTORY REVIEW: RESULT: NO ABNORMALITY, THERE WAS NO RECORD IN THE MANUFACTURING RECORDS OF DEFECTS SUCH AS SCRATCHES, BENDS, OR BREAKS IN THE CANULA. 4. DECISION AND JUSTIFICATION: THIS COMPLAINT IS CONSIDERED AS NOT CONFIRMED. THE INVESTIGATION INTO THIS COMPLAINT CONSISTED OF A REVIEW OF THE MANUFACTURING RECORDS OF THE BULK NEEDLE PRODUCT IN QUESTION, A VISUAL INSPECTION OF RETENTION SAMPLES, AND A STIFFNESS TEST TO CONFIRM THE STRENGTH OF THE CANNULA. (RESULTS): NO ABNORMALITIES WERE FOUND IN THE MANUFACTURING RECORDS. THE STIFFNESS TEST SHOWED NO PROBLEMS WITH THE STRENGTH OF THE CANNULA.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: DURING A CESAREAN SECTION USING SPINAL ANESTHESIA, AFTER SEVERAL ATTEMPTS, A DEFECT IN THE SPINAL NEEDLE WAS NOTICED (ABSENCE OF THE DISTAL END OF THE NEEDLE, ABOUT 4 CM LONG).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2435843 PENCAN® NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP B BRAUN MELSUNGEN AG 23D24H8B01 04046964180989

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention