BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBIF SYRINGE

    MDR report key: 2274404 · Received October 3, 2011

    Report

    Report Number
    1220970-2011-00001
    Event Type
    Injury
    Date Received
    October 3, 2011
    Date of Event
    August 5, 2011
    Report Date
    September 7, 2011
    Manufacturer
    EMD SERONO, INC.
    Product Code
    MJN
    PMA / PMN Number
    103780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION WAS PERFORMED ON RETAIN ASSESSMENT/BATCH REVIEW SEMIFINISHED BATCH NUMBER BA002408 MFG IN (B)(4), USED IN FINISHED PRODUCT BATCH NUMBER AU001168 PACKED IN (B)(4). QUALITY CONTROL RESULTS AT RELEASE TIME CONFIRMED THE CONFORMITY OF THE BATCH OF THE SEMIFINISHED BATCH NUMBER BA002408, THE REVIEW OF THE BATCH RECORD OF THE SEMIFINISHED PRODUCT DID NOT SHOW ANY ISSUE DURING THE MFG PROCESS WHICH COULD BE LINKED TO THIS KIND OF COMPLAINTS, AND THE REVIEW OF THE RETAIN SAMPLES OF THE SEMIFINISHED PRODUCT DID NOT SHOW ANY ANOMALY. MOREOVER THE NEEDLE CAP IS NEVER REMOVED DURING ALL PRODUCTION / FILLING OPERATIONS OF THE SEMIFINISHED PRODUCT. THERE WAS NOT EVIDENCE THAT THE PROBLEM WAS CAUSED BY A MFG ISSUE AT THE MFG SITE. UNUSED SYRINGES FROM THE SAME BATCH WERE RETURNED FROM THE PT AND RECEIVED AT EMD SERONO, INC ON (B)(4) 2011. FIVE REBIF 44 MCG SYRINGES RECEIVED (LOT #AU001168, EXP 01/2013), WERE RECEIVED IN A PADDED ENVELOPE. THE SYRINGES ARE UNUSED AND IN THEIR SEALED BLISTER TRAYS. THE VISUAL APPEARANCE OF THE SYRINGES DO NOT SHOW ANY DEFORMITIES. THE BLISTER TRAYS ARE FREE OF DAMAGE. THE SYRINGES WILL BE FORWARDED TO THE MFR FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    THIS CASE REPORT RECEIVED FROM A PT IN (B)(6) WAS RECEIVED AT EMD SERONO ON (B)(6) 2011. THIS (B)(6) MALE PT'S REBIF NEEDLE BROKE OFF INSIDE HIS RIGHT LEG AND THE NEEDLE SHIFTED INTO THE TISSUES, WHICH WAS ASSESSED AS MEDICALLY SIGNIFICANT BY THE COMPANY, WHILE BEING TREATED WITH REBIF. MEDICAL HISTORY INCLUDED MULTIPLE SCLEROSIS DIAGNOSED ON (B)(6) 1983 THAT WAS ONGOING. NO CONCOMITANT MEDICATIONS WERE REPORTED. THE PT RECEIVED REBIF (INTERFERON BETA-LA) FROM AT AN UNK TIME PERIOD AND RESUMED ADMINISTRATIONS ON (B)(6) 2011 AT 44 MCG THREE TIMES PER WEEK BY SUBCUTANEOUS INJECTION FOR MULTIPLE SCLEROSIS. ADMINISTRATIONS WERE ONGOING AT THE TIME OF THE EVENT. ON (B)(6) 2011, A REBIF NEEDLE BROKE OFF INSIDE IN HIS RIGHT LEG. THE PT WENT TO THE ER, AND IT TOOK THE PHYSICIAN 45 MINUTES TO EXTRACT THE NEEDLE. BY WALKING THE NEEDLE HAD SHIFTED INTO THE TISSUES ABOUT TWO INCHES DOWN FROM SITE. ON (B)(6) 2011, ANOTHER REBIF NEEDLE BROKE OFF. THE PT HAD TO HAVE THE NEEDLE SURGICALLY REMOVED BY A SURGEON. AS OF (B)(6) 2011, THE PT HAD TWO HUGE HOLES IN HIS LEG AND IT WAS VERY PAINFUL. THE PT WAS TAKING PERCOCET (OXYCODONE AND ACETAMINOPHEN), WHICH WAS NOT HELPING. THE PT MANUALLY INJECTS, HAD BEEN TAKING REBIF FOR YRS, AND KNEW WHAT HE WAS DOING. THE PT HAD USED THREE SYRINGES FROM THE SAME BOX WITH NO ISSUE. THE STAFF AT THE PHYSICIAN'S OFFICE WAS NOT AWARE THAT THIS HAPPENED TO THE PT NOR WERE THEY AWARE OF THE INJECTION TECHNIQUE THAT THE PT USED. THE STAFF FURTHER WENT ON TO SAY THAT THE PT WAS NOT RELIABLE AND THEY WERE HAVING A HARD TIME BELIEVING THIS EVENT EVER HAPPENED. THE PT CONTINUED ADMINISTRATIONS OF REFIB. AT THE TIME OF REPORTING, THE NEEDLES HAD BEEN REMOVED FROM THE PT HOWEVER HE CONTINUED TO COMPLAIN OF PAIN AND BIG HOLES IN THE AREA. THE PHYSICIAN WAS NOT AWARE OF THE EVENT AND THEREFORE DID NOT PROVIDE A CAUSAL RELATIONSHIP BETWEEN THE REBIF AND THE EVENTS. F/U INFO RECEIVED FROM THE PT ON (B)(6) 2011 INCLUDED CORRECTED LOT NUMBER AND EVENT DETAILS. F/U INFO RECEIVED FROM THE STAFF AT A PHYSICIAN'S OFFICE ON (B)(6) 2011 INCLUDED INFO ABOUT PT AND NO CONFIRMATION THAT EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REBIF SYRINGE BOROSILICATE TYPE I GLASS BARREL SYRINGE MJN EMD SERONO, INC. F67B01A1 AU001168

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention NO CONCOMITANT MEDICAL PRODUCTS WERE REPORTED.