BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVIDREL SYRINGE

    MDR report key: 2875047 · Received December 11, 2012

    Report

    Report Number
    1220970-2012-00001
    Event Type
    Injury
    Date Received
    December 11, 2012
    Date of Event
    November 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    EMD SERONO, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION WAS PERFORMED ON RETAIN ASSESSMENT/BATCH NUMBER BA008382 MANUFACTURED IN MERCK SERONO-BARI. BATCH BA008382 DID NOT REVEAL ANY ANOMALY AND/OR DEVIATION WHICH COULD HAVE A POTENTIAL LINK WITH THE ISSUE REPORTED. THE RETENTION SAMPLE IS CONFORM AND NEEDLE IS NORMALLY ATTACHED TO THE SYRINGE. THE BATCH OF THE SEMI-FINISHED PRODUCT USED TO PACK THIS BATCH IS BA007659 FILLED WITH THE BACH OF SYRINGES (B)(4). THIS WAS LAST USED TO FILL OTHER BATCHES OF SEMI-FINISHED PRODUCT (REBIF) DISTRIBUTED TO OTHER COUNTRIES (E.G. (B)(4)) AND NO SIMILAR COMPLAINT WAS RECEIVED.

    Description of Event or Problem · 1

    THIS CASE REPORT RECEIVED FROM A PATIENT IN THE USA WAS RECEIVED AT EMD SERONO ON (B)(6) 2012. THIS IS (B)(6) FEMALE PATIENT'S OVIDREL NEEDLE BROKE OFF INSIDE THE INJECTION SITE ON HER ABDOMEN, WHICH WAS ASSESSED AS A MEDICALLY SIGNIFICANT EVENT BY THE COMPANY, WHILE BEING TREATED WITH OVIDREL. MEDICAL HISTORY INCLUDED INFERTILITY AND THE PATIENT WAS NORMAL HEIGHT AND WEIGHT. NO CONCOMITANT MEDICATIONS WERE REPORTED. THE PATIENT RECEIVED OVIDREL (CHORIOGONADOTROPIN ALFA INJECTION) FOR THREE CYCLES FOR INFERTILITY THAT WAS ONGOING AT THE TIME OF EVENT. ON (B)(6) 2012, DURING THE PATIENT'S THIRD CYCLE OF OVIDREL, THE PATIENT GAVE HERSELF THE INJECTION AND THE NEEDLE BROKE OFF FROM HER SYRINGE AND BECAME STUCK IN HER ABDOMEN. THE PATIENT DID REPORT THAT THE NEEDLE APPEARED SLIGHTLY BENT PRIOR TO USE, BUT THERE WAS NO OTHER APPARENT DAMAGE TO THE SYRINGE OR THE TRAY AND THE CARTON APPEARED NORMAL. THE PATIENT FOLLOWED THE INJECTION INSTRUCTIONS FOR OVIDREL THAT WERE ONLINE. THE PATIENT WENT TO THE EMERGENCY ROOM AND X-RAY CONFIRMED THAT THE NEEDLE WAS IN HER ABDOMEN. A SURGEON WAS CONSULTED AND THE PATIENT WAS PROVIDED WITH THE OPTION TO HAVE THE NEEDLE SURGICALLY REMOVED BY A PLASTIC SURGEON, OR TO LEAVE IT ALONE, AS SHE WAS TRYING TO GET PREGNANT. THE PATIENT MADE THE DECISION TO LEAVE THE NEEDLE WHERE IT WAS A THAT TIME. AS ON (B)(6) 2012, THE PATIENT HAD NOT YET DECIDED WHETHER OR NOT TO HAVE THE NEEDLE SURGICALLY REMOVED OR NOT AND WAS ON HER FOURTH CYCLE OF OVIDREL. AT THE TIME OF REPORTING, THE PATIENT HAD NOT YET RECOVERED FROM THE NEEDLE BREAKING OF INSIDE THE INJECTION SITE ON HER ABDOMEN AND HAD NOT YET RECEIVED ANY INTERVENTION. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT ON (B)(6) 2012, INCLUDED: EVENT DETAILS, OUTCOME, MEDICAL HISTORY, AND OVIDREL THERAPY DETAILS. ADDITIONAL INFORMATION RECEIVED FROM MERCK SERONO-BARI ON (B)(6) 2012, INCLUDED AN INVESTIGATION OF THE RETAIN ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVIDREL SYRINGE BROSILICATE TYPE I GLASS BARREL SYRINGE FMF EMD SERONO, INC. F54G0102 BA008382

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other NO CONCOMITENT MEDICAL PRODUCTS WERE REPORTED.