BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE

    MDR report key: 17699222 · Received September 7, 2023

    Report

    Report Number
    2243072-2023-01580
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    March 21, 2023
    Report Date
    September 21, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. PLEASE NOTE THAT INTRAOCULAR APPLICATION IS NOT WITHIN THE INTENDED USE OF MATERIAL 309628. PER LABELING, BD DOES NOT VALIDATE MATERIAL 309628 FOR INTRAOCULAR USE. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 0

    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 FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. 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 · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE HAD FOREIGN MATTER PRESENT. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: A 2017 STUDY COMPARING VARIOUS SYRINGES USED IN IVI SHOWED THAT SODS APPEARED AT THE END OF INJECTIONS WITH FIXED-NEEDLE INSULIN SYRINGES WHEN THE PLUNGER WAS COMPLETELY DEPRESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE HAD FOREIGN MATTER PRESENT. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: A 2017 STUDY COMPARING VARIOUS SYRINGES USED IN IVI SHOWED THAT SODS APPEARED AT THE END OF INJECTIONS WITH FIXED-NEEDLE INSULIN SYRINGES WHEN THE PLUNGER WAS COMPLETELY DEPRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292984 BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown