BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PLASTIPAK SYRINGE

    MDR report key: 2767031 · Received September 26, 2012

    Report

    Report Number
    2243072-2012-00016
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 23, 2012
    Report Date
    September 25, 2012
    Manufacturer
    BD
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED BY CIFARMA, A PHARMACEUTICAL COMPANY. CIFARMA USES BD SYRINGES AS PART OF ITS PRODUCT. ACCORDING TO CIFARMA 5 BD LOTS WERE USED IN PRODUCTION OF THE CIFARMA PRODUCT RELATED TO THIS EVENT. THE INCIDENT CANNOT BE NARROWED TO ONE LOT, SINCE CIFARMA USED MULTIPLE LOTS (LOT # 1118765, 1150903, 1129363, 1133464, 1129358) IN ITS PRODUCT. ALL REPORTED LOTS WERE MANUFACTURED IN 05/2011. EVAL SUMMARY: RETENTION SAMPLES FROM REPORTED LOTS WERE TESTED FOR LEAKAGE AND NO FAILURE WERE NOTED. ON A LATER DATE, SAMPLE WAS RETURNED FROM CUSTOMER. THE RETURNED SAMPLE IS UNDER INVESTIGATION. COMPLAINT HISTORY CHECK YIELDED NO OTHER COMPLAINTS FOR SIMILAR CONDITION FOR THE LOTS REPORTED. DEVICE HISTORY REVIEW WAS CONDUCTED FOR REPORTED LOTS AND NO ANOMALIES NOTED. QUALITY WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    DURING ADMINISTRATION OF THE CONTRACEPTIVE, THE SYRINGE DISCONNECTED FROM THE NEEDLE AND THE DRUG SPLATTERED IN THE PHARMACIST FACE AND EYE. THE PHARMACIST HAD AN EYE IRRITATION AND WENT TO OPHTHALMOLOGIST AND WAS PRESCRIBED AN EYE DROP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PLASTIPAK SYRINGE 3ML PLASTIPAK SYRINGE FMF BD MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention