BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 5123945 · Received October 2, 2015

    Report

    Report Number
    1213809-2015-00008
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    September 10, 2015
    Report Date
    December 17, 2015
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 4024038.CONCLUSIONS - AS THERE WAS NO ACTUAL SAMPLE RETURNED FOR EVALUATION, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE USED, ACTIVATED BD 3ML 25G INTEGRA RETRACTABLE SYRINGE (CAT # 305270, LOT # 4024038) WAS RECEIVED OUT OF AN OPEN BLISTERPACK ON 12/1/2015. ISSUE - NEEDLE BREAK OFF IN INJECTION SITE. RESULT: THE SAMPLE WAS BROKEN DOWN AND REVEALED THE 25G CANNULA HAVING RETRACTED AND RESTING INSIDE THE BARREL. CONCLUSION: THIS ISSUE IS NOT CONFIRMED BASED OFF THE SAMPLE INVESTIGATION AS THE NEEDLE WAS FOUND IN THE RETURNED SAMPLE. ISSUE - LEAKAGE OF MEDICATION AT THE INJECTION SITE. RESULT: THE RETURNED SAMPLE WAS EXAMINED AND NO DAMAGE, CRACKS OR DEFORMITY OF THE PLUNGER, STOPPER, NEEDLE HUB OR SYRINGE BARREL WAS OBSERVED. ON INTEGRA SYRINGES, IF THE MEDICATION IS TOO VISCOUS, OR IF THE NEEDLE GAUGE IS TOO SMALL, THE ADMINISTRATOR WOULD EXPERIENCE COUNTER PRESSURE WHEN TRYING TO DISPEL MEDICATION. IN SOME CASES, THE BLADE MIGHT PROTRUDE THROUGH THE STOPPER AHEAD OF TIME, FOR INSTANCE HALFWAY THROUGH THE ADMINISTRATION, AND THE SYRINGE MAY BOTTOM OUT OR JAM WITH APPROXIMATELY 0.1 ML OF THE MEDICATION STILL WITHIN THE BARREL. THE ABOVE SCENARIO MAY CAUSE THIS MEDICATION TO LEAK OUT THE BARREL HUB. CONCLUSION: THIS ISSUE IS NOT CATEGORIZED AS A DEVICE MALFUNCTION AND CANNOT BE CONFIRMED BASED ON SAMPLE INVESTIGATION. ISSUE - BUMP ON THE INJECTION SITE. RESULT: THE NEEDLE WAS INSPECTED UNDER MAGNIFICATION FOR ANY ISSUES WITH THE NEEDLE TIP THAT WOULD CAUSE A BUMP OR SWELLING ON THE INJECTION SITE. THE TIP WAS NOTED TO BE DULL. IT COULD NOT BE ESTABLISHED IF THIS WAS SINCE THE NEEDLE HAD BEEN USED. THERE IS NO INDICATION OF ANY ISSUE WHILE INJECTING WITH REFERENCE TO PAIN OR DIFFICULT INJECTION PER THE CUSTOMER'S COMPLAINT VERBATIM. THE RESULT OF THE DEVICE HISTORY REVIEW INDICATES THAT ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO ISSUES RELATED TO THE DEFECT DESCRIBED IN THIS COMPLAINT OBSERVED DURING MANUFACTURING PROCESS OF BATCH 4024038. ALL VISUAL INSPECTIONS WERE ALSO PERFORMED AS PER REQUIREMENT WITH NO ISSUES OBSERVED DURING MANUFACTURING PROCESS OF THE ASSEMBLY BATCHES USED TO PRODUCE THE PACKAGED BATCH 4024038. NO VISUAL FM COULD BE SEEN ON THE NEEDLE THAT COULD HAVE CONTRIBUTED TO AN ALLERGIC REACTION. CONCLUSION: THIS ISSUE IS CONFIRMED BASED ON THE DULL NEEDLE POINT NOTED.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR INVESTIGATION BUT HAS NOT BEEN RECEIVED. A SUPPLEMENTAL WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    PER REPORT, AN INTEGRA SYRINGE NEEDLE BROKE OFF DURING INJECTION OF TESTOSTERONE INTO BUTTOCKS. THE CUSTOMER WENT TO THE ED AND RECEIVED AN X-RAY. THE NEEDLE WAS NOT SEEN. CUSTOMER STATES HE HAS LIQUID COMING OUT OF INJECTION SITE AND CAN FEEL A BUMP. CONSUMER WENT TO THE PHARMACY AND HAD THE SYRINGE INSPECTED. IT WAS DETERMINED THAT THE NEEDLE WAS NOT INSIDE THE SYRINGE. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655345 25 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE SYRINGE AND NEEDLE, BD SAFETY-ENGINEERED DEVICE MEG BECTON DICKINSON MEDICAL SYSTEMS 4024038

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention