BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY¿

    MDR report key: 6650028 · Received June 19, 2017

    Report

    Report Number
    2134265-2017-05982
    Event Type
    Malfunction
    Date Received
    June 19, 2017
    Date of Event
    May 24, 2017
    Report Date
    May 24, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED IN AN OPENED OUTER BOX. THE GSI BARCODE LABEL ON THE BACK OF THE BOX WAS LABELLED WITH TWO DIFFERENT STENT SIZES. THE LOWER PEEL OFF LABEL (GSI BARCODE) WAS NOTED TO BE AN OVER LABEL AND AS A RESULT THERE WERE TWO DIFFERENT BATCH NUMBERS DISPLAYED, 2.75X24MM (FINISHED GOODS BATCH (FGB) 19377125) AND 2.75X20MM (FGB 19444376). THERE WAS A BARCODE LABEL ON THE RIGHT HAND SIDE OF THE BOX WITH THE FOLLOWING REFERENCE BAR CODE (B)(4). THE FOIL POUCH AND THE CLEAR POUCH WERE OBSERVED TO BE SEALED AND THE DEVICE WAS STILL INSIDE THE HOOP. THE MANIFOLD READING WAS NOTED TO BE 2.75 X 24MM. IT WAS NOTED THAT THE DISPATCH CENTRE BARCODE (01)(B)(4). WAS MATCHING THE BARCODE ON THE INNER PACKAGING I.E. BOTH THE FOIL POUCH AND CLEAR POUCH. DURING ANALYSIS AN ATTEMPT WAS MADE TO REMOVE THE LOWER PEEL LABEL WHICH WAS STUCK ON THE OUTER PACKAGING AS AN OVER LABEL BUT IT WAS NOT POSSIBLE TO REMOVE THE OVER LABEL HOWEVER IT DID APPEAR THAT THE LABEL UNDERNEATH READ 2.75 X 24MM. FINDINGS AND REVIEWS OF THE MANUFACTURING PROCESS CONFIRMED THAT ALL DEVICES FROM FGB 19444376 AND FGB 19377125 WERE LABELLED CORRECTLY PRIOR TO SHIPPING. THE BATCHES WERE MANUFACTURED AND SHIPPED ON DIFFERENT DATES SO THERE WERE NO POSSIBILITIES OF BATCH MIX UP. THE DISPATCH CENTRE (B)(4) CONFIRMED THAT THE TWO BATCHES WERE LABELLED CORRECTLY AT (B)(4) DISTRIBUTION CENTRE AND SHIPPED TO THE SAME HOSPITAL ON DIFFERENT DATES. BASED ON THE MANUFACTURING REVIEWS, DEVICE HISTORY RECORD (DHR) FINDINGS AND ANALYSIS RESULTS, THE OVER LABEL WAS MOST LIKELY STUCK ON TO THE OUTER PACKAGING BOX AT THE CUSTOMER¿S FACILITY. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED. BSC ID (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LABELING ERROR. A BSC REPRESENTATIVE WAS CONDUCTING A CONSIGNMENT REVIEW AND NOTED THE LABELING ON THE OUTER BOX OF A SYNERGY STENT WAS INCONSISTENT. THERE WERE TWO LABELS THAT SHOWED TWO DIFFERENT PART NUMBERS, LOT NUMBERS AND PRODUCT SIZES. THE PRODUCT WAS REMOVED FROM THE SHELF, THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LABELING ERROR. A BSC REPRESENTATIVE WAS CONDUCTING A CONSIGNMENT REVIEW AND NOTED THE LABELING ON THE OUTER BOX OF A SYNERGY STENT WAS INCONSISTENT. THERE WERE TWO LABELS THAT SHOWED TWO DIFFERENT PART NUMBERS, LOT NUMBERS AND PRODUCT SIZES. THE PRODUCT WAS REMOVED FROM THE SHELF, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430661 SYNERGY¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493926224270 19377125

    Patients

    Seq Age Sex Outcome Treatment
    1