BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SYRINGE SAFETY 3ML LL 22X1

    MDR report key: 9266715 · Received November 1, 2019

    Report

    Report Number
    2243072-2019-02443
    Event Type
    Injury
    Date Received
    November 1, 2019
    Date of Event
    October 2, 2019
    Report Date
    November 22, 2019
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED BY CUSTOMER REGARDING THE PRODUCT ON THIS COMPLAINT. THE PRODUCT INITIALLY REPORTED WAS IN A DIFFERENT INTERNAL BUSINESS UNIT. IT HAS BEEN DETERMINED THAT THIS COMPLAINT WILL BE CANCELED. THE NEW COMPLAINT HAS BEEN SUBMITTED UNDER MFR REPORT# 1920898-2019-01322. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AFTER INJECTION IN EYE, SILICONE WAS INJECTED WHICH REMAINED IN THE EYE AND NOW IS SEEING "FLOATERS" WITH A BD SYRINGE SAFETY 3ML LL 22X1. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3 COMPLAINTS). IT WAS REPORTED THAT THE PATIENT RECEIVED AN INJECTION IN THEIR EYE AND SILICONE WAS INJECTED, WHICH REMAINS IN THEIR EYE, AND AS A RESULT IS SEEING "FLOATERS". ADDITIONAL INFO PROVIDED BY DR. OFFICE STATES, "PT IS FEMALE. SHE HAD AN INJECTION INTO HER RIGHT EYE ON (B)(6)19. WE SAW HER IN FOLLOW UP ON (B)(6)19 WHERE THE DIAGNOSIS OF RETAINED SILICONE OIL BUBBLES WAS CONFIRMED BY DR. WE ARE SEEING HIM AGAIN IN NOV FOR MORE IMAGING AND TREATMENT AS USUAL." D.1. MEDICAL DEVICE BRAND NAME: BD SYRINGE SAFETY 3ML LL 22X1. D.1 MEDICAL DEVICE TYPE: N/A. D.2. COMMON DEVICE NAME: PISTON SYRINGE. D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON IND. CIRURGICAS LTDA ¿ CURITIBA, BRAZIL/81170-230. D.4 MEDICAL DEVICE CATALOG #: 307862. D.4. MEDICAL DEVICE LOT #: 9014709. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.2 MANUFACTURING LOCATION: BECTON DICKINSON IND. CIRURGICAS LTDA ¿ CURITIBA, BRAZIL/81170-230. G.5. PMA / 510(K)#:N/A. H.4. DEVICE MANUFACTURE DATE: 2019-01-14.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INJECTION IN EYE, SILICONE WAS INJECTED WHICH REMAINED IN THE EYE AND NOW IS SEEING "FLOATERS" WITH AN UNSPECIFIED BD SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3 COMPLAINTS) IT WAS REPORTED THAT THE PATIENT RECEIVED AN INJECTION IN THEIR EYE AND SILICONE WAS INJECTED, WHICH REMAINS IN THEIR EYE, AND AS A RESULT IS SEEING "FLOATERS". ADDITIONAL INFO PROVIDED BY DR. OFFICE STATES, "PT IS FEMALE. SHE HAD AN INJECTION INTO HER RIGHT EYE ON OCT (B)(6). WE SAW HER IN FOLLOW UP ON OCT (B)(6) WHERE THE DIAGNOSIS OF RETAINED SILICONE OIL BUBBLES WAS CONFIRMED BY DR. WE ARE SEEING HIM AGAIN IN NOV FOR MORE IMAGING AND TREATMENT AS USUAL."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INJECTION IN EYE, SILICONE WAS INJECTED WHICH REMAINED IN THE EYE AND NOW IS SEEING "FLOATERS" WITH A BD SYRINGE SAFETY 3ML LL 22X1. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3 COMPLAINTS). IT WAS REPORTED THAT THE PATIENT RECEIVED AN INJECTION IN THEIR EYE AND SILICONE WAS INJECTED, WHICH REMAINS IN THEIR EYE, AND AS A RESULT IS SEEING "FLOATERS". ADDITIONAL INFO PROVIDED BY DR. OFFICE STATES, "PT IS FEMALE. SHE HAD AN INJECTION INTO HER RIGHT EYE ON (B)(6)19. WE SAW HER IN FOLLOW UP ON (B)(6)19 WHERE THE DIAGNOSIS OF RETAINED SILICONE OIL BUBBLES WAS CONFIRMED BY DR. WE ARE SEEING HIM AGAIN IN NOV FOR MORE IMAGING AND TREATMENT AS USUAL."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INJECTION IN EYE, SILICONE WAS INJECTED WHICH REMAINED IN THE EYE AND NOW IS SEEING "FLOATERS" WITH AN UNSPECIFIED BD SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3 COMPLAINTS). IT WAS REPORTED THAT THE PATIENT RECEIVED AN INJECTION IN THEIR EYE AND SILICONE WAS INJECTED, WHICH REMAINS IN THEIR EYE, AND AS A RESULT IS SEEING "FLOATERS". ADDITIONAL INFO PROVIDED BY DR. OFFICE STATES, "PT IS FEMALE. SHE HAD AN INJECTION INTO HER RIGHT EYE ON (B)(6) 2019. WE SAW HER IN FOLLOW UP ON OCT 15/19 WHERE THE DIAGNOSIS OF RETAINED SILICONE OIL BUBBLES WAS CONFIRMED BY DR. WE ARE SEEING HIM AGAIN IN NOV FOR MORE IMAGING AND TREATMENT AS USUAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059453 BD SYRINGE SAFETY 3ML LL 22X1 PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 9014709

    Patients

    Seq Age Sex Outcome Treatment
    1 Other