BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 13966527 · Received March 31, 2022

    Report

    Report Number
    1213809-2022-00162
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 11, 2022
    Report Date
    May 24, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 21-APR-2022. H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1040286. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, MULTIPLE SAMPLES WERE SUBMITTED TO AID IN OUR INVESTIGATION. OUR ENGINEERS NOTED THAT ALL OF THE SUBMITTED SAMPLES, EXHIBITED A FOGGY RESIDUE AROUND THE INTERIOR CIRCUMFERENCE OF THE DEVICE. REPORTED ISSUE HAS BEEN CONFIRMED. AFTER IDENTIFICATION, THE SAMPLES WERE SUBMITTED FOR COMPOSITIONAL TESTING. RESULTS POSITIVELY IDENTIFIED THE RESIDUE AS SILICONE LUBRICANT. SILICONE IS A VITAL COMPONENT OF THE MANUFACTURING PROCESS, AND ALLOWS FOR THE PISTON TO GLIDE INSIDE OF THE SYRINGE, IT IS A SAFE AND COMMONLY USED COMPONENT IN THE MEDICAL DEVICE INDUSTRY. UNFORTUNATELY, OUR ENGINEERS WERE UNABLE TO CONFIRM THE ROOT CAUSE FOR THIS EVENT AT THE CONCLUSION OF THEIR INVESTIGATION. THEY SPECULATE THAT ENVIRONMENTAL CONDITIONS DURING TRANSPORTATION AND STORAGE OF THE DEVICE MAY HAVE CAUSED THE BINDING OF THE SILICONE TO THE SYRINGE WALL, BUT THIS CANNOT BE CONFIRMED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS VISIBLE INSIDE OF THE BD LUER-LOK¿ SYRINGE. THIS EVENT OCCURRED 23 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS AN UNCLEAR AREA INSIDE OF THE SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS VISIBLE INSIDE OF THE BD LUER-LOK¿ SYRINGE. THIS EVENT OCCURRED 23 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS AN UNCLEAR AREA INSIDE OF THE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344614 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 1040286 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown