BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM FOR SOFT TISSUE GRAFT - STERILE PRODUCTS

    MDR report key: 22122743 · Received June 2, 2025

    Report

    Report Number
    3004549189-2025-00008
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    March 26, 2025
    Report Date
    June 30, 2025
    Manufacturer
    S.B.M. SAS
    Product Code
    MBI
    PMA / PMN Number
    K151004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDWATCH CREATED ON APRIL 14, 2025. FOR INFORMATION. NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER. ADDITIONAL INFORMATION ON MARCH 27, 2025: THE LABEL ON THE ITEM DOES NOT MATCH THE CERTIFICATE". THESE PRODUCTS HAVE INCORRECT MANUFACTURE / EXPIRY DATES ON THE OUTER AND TRACEABILITY LABELS. MANUFACTURING DATE: 02/03/2030 INSTEAD OF 02/03/2025. EXPIRY DATE: 01/03/2035 INSTEAD OF 01/03/2030. VERIFICATION OF MANUFACTURING DATA: IDENTIFY THE CAUSE OF THE ANOMALY: INCORRECT INFORMATION IN THE DATA SUPPLIED TO THE LABEL PRINTER. REQUEST TO THE DISTRIBUTOR TO ISOLATE THE PRODUCT CONCERNED (1 BOX). VERIFICATION OF INTERNAL STOCK LOT: 251174: 7 BOXES ISOLATED. THIS BATCH NUMBER WAS DELIVERED IN UNITED KINGDOM AND IN FRANCE - THE PRODUCTS ARE BEING RECALLED. USA IS NOT CONCERNED BY THIS BATCH RECALL / THERE ARE NO CUSTOMERS CONCERNED IN USA MARKET. THE DEVICES OF THIS BATCH NUMBER ARE DISTRIBUTED IN THE UK MARKET AND FRANCE MARKET ONLY. JUNE 02, 2025. DECLARATION SENT FOR REGULARIZATION FOLLOWING CHANGEOVER TO ESG NEXT GEN. RECONCILIATION OF THE BATCH RECALL IS BEING FINALIZED.

    Additional Manufacturer Narrative · 0

    MEDWATCH CREATED ON APRIL 14, 2025 FOR INFORMATION. NO OTHER COMPLAINT CONCERNING THIS BATCH NUMBER. ADDITIONAL INFORMATION ON MARCH 27, 2025: THE LABEL ON THE ITEM DOES NOT MATCH THE CERTIFICATE". THESE PRODUCTS HAVE INCORRECT MANUFACTURE / EXPIRY DATES ON THE OUTER AND TRACEABILITY LABELS. MANUFACTURING DATE: 02/03/2030 INSTEAD OF 02/03/2025. EXPIRY DATE: 01/03/2035 INSTEAD OF 01/03/2030. VERIFICATION OF MANUFACTURING DATA - IDENTIFY THE CAUSE OF THE ANOMALY: INCORRECT INFORMATION IN THE DATA SUPPLIED TO THE LABEL PRINTER. REQUEST TO THE DISTRIBUTOR TO ISOLATE THE PRODUCT CONCERNED (1 BOX). VERIFICATION OF INTERNAL STOCK LOT 251174: 7 BOXES ISOLATED. THIS BATCH NUMBER WAS DELIVERED IN UNITED KINGDOM AND IN FRANCE - THE PRODUCTS ARE BEING RECALLED - USA IS NOT CONCERNED BY THIS BATCH RECALL / THERE ARE NO CUSTOMERS CONCERNED IN USA MARKET - THE DEVICES OF THIS BATCH NUMBER ARE DISTRIBUTED IN THE UK MARKET AND FRANCE MARKET ONLY. ____________________________________________________ JUNE 02, 2025 DECLARATION SENT FOR REGULARIZATION FOLLOWING CHANGEOVER TO ESG NEXT GEN. RECONCILIATION OF THE BATCH RECALL IS BEING FINALIZED. ____________________________________________________ JUNE 30, 2025 SBM HAS CONDUCTED A FIELD ACTION IN UK AND FRANCE - THE FSCA IS NOW CONSIDERED CLOSED. USA WAS NOT CONCERNED BY THIS BATCH RECALL. VERY ISOLATED INCIDENT. CORRECTIVE ACTION: *MEETING WITH PRODUCTION STAFF ON 03 APRIL 25 TO REMIND THEM OF THE IMPORTANCE OF SELF-CONTROLS ON PACKAGING, AND THE IMPACT WHEN THESE ARE NOT CARRIED OUT. *DISTRIBUTION OF MEMO AQ/2025/03 TO REMIND EMPLOYEES OF GOOD LABEL CONTROL PRACTICES. *REINFORCED CONTROL FROM MID-APRIL TO JUNE 2025: LABELS PREPARED ON FRIDAYS ARE CONTROLLED ON MONDAYS BY THE QUALITY DEPARTMENT BEFORE USE (CONTROL OF THE LABEL AFFIXED TO THE (B)(4) PRODUCTION LABELING SHEET + CONTROL OF LABELS ISSUED BY SAMPLING). NO RECURRENCE.

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURED IN THE UNITED KINGDOM. NOTIFICATION OF ANOMALY ON RECEIPT AT THE DISTRIBUTOR'S SITE. COMPLAINT DESCRIPTION BY OUR DISTRIBUTOR: "THE STERILIZATION AND USE BEFORE DATE FOR ITEM: PULX01202, BATCH: 251174, IS INCORRECT ON THE STERILIZATION CERTIFICATE. THE CORRECT DETAILS SHOULD READ STERILIZATION DATE 02/03/2030 AND USE BEFORE 01/03/2035".

    Description of Event or Problem · 0

    FN CONF-25-0067 INCIDENT OCCURED IN THE UNITED KINGDOM. NOTIFICATION OF ANOMALY ON RECEIPT AT THE DISTRIBUTOR'S SITE. COMPLAINT DESCRIPTION BY OUR DISTRIBUTOR: "THE STERILIZATION AND USE BEFORE DATE FOR ITEM PULX01202, BATCH 251174, IS INCORRECT ON THE STERILIZATION CERTIFICATE. THE CORRECT DETAILS SHOULD READ STERILIZATION DATE 02/03/2030 AND USE BEFORE 01/03/2035".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843597 SYSTEM FOR SOFT TISSUE GRAFT - STERILE PRODUCTS PULLUP®XL ADJUSTABLE FIXATION SYSTEM FOR LIGAMENT RECONSTRUCTION MBI S.B.M. SAS 251174

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown Other