BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD FLUNT FILL NEEDLE WITH FILTER

    MDR report key: 9682030 · Received February 7, 2020

    Report

    Report Number
    1911916-2020-00108
    Event Type
    Injury
    Date Received
    February 7, 2020
    Date of Event
    October 16, 2019
    Report Date
    January 31, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES WERE RECEIVED. TWO PHOTOS WERE PROVIDED. THEY SHOW A 1ML SYRINGE AND TWO NEEDLE ASSEMBLY PACKAGING BLISTERS ONE IS FOR A 30X ½ AND OTHER FOR 18X 1 ½ FILL NEEDLE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: ROOT CAUSE FOR THE REPORTED ISSUE CANNOT BE DETERMINED AS SAMPLES WOULD BE NEEDED FOR EVALUATION. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD FLUNT FILL NEEDLE WITH FILTER HAD FOREIGN MATTER WAS FOUND IN THE PATIENTS EYE AFTER INJECTION. INFLAMMATION OCCURRED ON 4 OCCASIONS DURING USE AND FOREIGN MATTER OCCURRED ON 5 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305211, BATCH NO.: 8173918. IT WAS REPORTED THAT SILICONE OIL DROPLETS AND METALLIC FLAKES WERE OBSERVED IN PATIENTS' EYE AFTER OCULAR INJECTION WHICH CAUSED SEVERAL CASES OF INFLAMMATION IN THE EYE. PR 3 OF 3: THIS PR IS FOR NEEDLE FILTER BLUNT FILL 18X1-1/2. PER COMPLAINT: WE ARE FACED WITH A TECHNICAL COMPLAINT WHERE THE DOCTOR OBSERVED THAT AFTER OCULAR INJECTION SILICONE OR SILICON LIKE DROPLETS WERE PRESENT IN THE EYE OF THE PATIENT WHICH CLAIMED IN 3 OF 4 CASES ABOUT EYE INFLAMMATION. ADDITIONALLY THE DOCTOR NOTICED "SMALL METALLIC, IRREGULARLY SHAPED SHIMMERING FLAKES FLOATING IN THE ANTERIOR VITREOUS". THEY OBSERVED AFTER OCULAR INJECTION USING THE SYRINGES AND NEEDLES PROVIDED FROM BD , SILICON OIL DROPLETS AND METALLIC FLAKES IN THE EYE OF THE PATIENT. THESE OBSERVATIONS WERE CONNECTED WITH AN INFLAMMATION OF THE EYES OF PATIENTS. FURTHERMORE WE WERE NOTIFIED THAT IT CAN BE A GENERAL ISSUE THAT SILICONE OIL DROPLETS ARE EXTRACTED FROM THE SYRINGE ONTO THE PRODUCT DOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145728 BD FLUNT FILL NEEDLE WITH FILTER MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 8173918 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 Other