BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA

    MDR report key: 9324639 · Received November 14, 2019

    Report

    Report Number
    1920898-2019-01295
    Event Type
    Injury
    Date Received
    November 14, 2019
    Date of Event
    October 1, 2019
    Report Date
    December 9, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    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

    CORRECTION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT FOREIGN MATTER OCCURRED AFTER USE WITH A SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT A CASE OF SILICONE BUBBLES POST AVASTIN INJECTION WAS CONFIRMED. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: FYI: WE HAVE JUST CONFIRMED ANOTHER CASE OF SILICONE BUBBLES POST AVASTIN INJECTION. INJECTION DATE WAS OCT 1/19. THE PT IS BOOKED FOR ONGOING INTRAOCULAR INJECTIONS, RIGHT EYE. WE DO NOT HAVE THE LOT # OF THE SYRINGES." 1 OF 2 COMPLAINTS. H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9070598. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION(B)(4) SILICONE OUTER DIAMETER OF BARREL. THERE WERE TWO (2) NOTIFICATIONS(B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: -UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. IT IS IMPORTANT TO NOTE BD ONLY MARKETS INSULIN DELIVERY SYRINGES FOR SUBCUTANEOUS USE. CONSISTENT WITH THE NAMING CONVENTION AND SCALE MARKING OF AN INSULIN SYRINGE, IT IS INSULIN-SPECIFIC, AND IT IS APPROVED BY HEALTH CANADA FOR THE INTENDED USE OF SUBCUTANEOUS INJECTION OF INSULIN. INSULIN SCALE MARK GRADATIONS ARE IN INSULIN UNITS AS OPPOSED TO ML FOUND ON GENERAL PURPOSE SYRINGES. BD DOES NOT INTEND FOR ITS INSULIN SYRINGES TO BE USED FOR ANY PURPOSE OTHER THAN SUBCUTANEOUS INJECTION OF INSULIN. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED AFTER USE WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "IT WAS REPORTED THAT A CASE OF SILICONE BUBBLES POST AVASTIN INJECTION WAS CONFIRMED. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: FYI: WE HAVE JUST CONFIRMED ANOTHER CASE OF SILICONE BUBBLES POST AVASTIN INJECTION. INJECTION DATE WAS (B)(6) 2019. THE PT IS BOOKED FOR ONGOING INTRAOCULAR INJECTIONS, RIGHT EYE. WE DO NOT HAVE THE LOT # OF THE SYRINGES."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED AFTER USE WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "IT WAS REPORTED THAT A CASE OF SILICONE BUBBLES POST AVASTIN INJECTION WAS CONFIRMED. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: FYI: WE HAVE JUST CONFIRMED ANOTHER CASE OF SILICONE BUBBLES POST AVASTIN INJECTION. INJECTION DATE WAS OCT (B)(6). THE PT IS BOOKED FOR ONGOING INTRAOCULAR INJECTIONS, RIGHT EYE. WE DO NOT HAVE THE LOT # OF THE SYRINGES." 1 OF 2 COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118800 SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA SYRINGE FMF BD MEDICAL - DIABETES CARE 9070598

    Patients

    Seq Age Sex Outcome Treatment
    1 Other