BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 8752988 · Received July 2, 2019

    Report

    Report Number
    1213809-2019-00690
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 17, 2019
    Report Date
    August 8, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE LOOSE 1ML SYRINGE WITH NEEDLE AND UNKNOWN CLEAR FLUID INSIDE WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS A CLEAR TRANSLUCENT FOREIGN MATTER PARTICLE FLOATING IN THE FLUID PATH NEAR THE STOPPER. IT APPEARED TO BE A PIECE OF PLASTIC FROM THE SYRINGE. IT WAS ALSO NOTICED AT THE TOP OF THE SYRINGE AND ON THE FLANGE, THE PLASTIC HAD A SWIRL-LIKE PATTERN WITH SOME TEXTURE. THE FOREIGN MATTER PARTICLE WAS LARGER THAN LEVEL 2 IN SIZE AND WAS REJECTABLE PER PRODUCT SPECIFICATION. THE BARREL WAS FROM MOLD L-90 CAVITY 32. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MATERIAL HANDLING PROCESS. THIS POTENTIALLY OCCURRED SHORTLY AFTER THE BARREL WAS RELEASED FROM THE CAST AND STILL WARM. AT WHICH TIME, THE TOP OF THE BARREL CONTACTED A HARD SURFACE AND CAUSED A SMALL PIECE OF THE BARREL TO BE PUSHED INSIDE. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS NOTICED IN THE EYLEA SOLUTION DRAWN UP BY THE BD SYRINGE LUER-LOK¿ TIP DURING USE. LOT #'S 7300853, 7240908, AND 7177895 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "PARTICULES/TROUBLE SOLUTION HAS BEEN IDENTIFIED BY THE DOCTOR INTO THE SYRINGE AFTER COLLECTING EYLEA SOLUTION INTO THE VIAL."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7300853, MEDICAL DEVICE EXPIRATION DATE: 2022-10-31, DEVICE MANUFACTURE DATE: 2017-12-04. MEDICAL DEVICE LOT #: 7240908, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, DEVICE MANUFACTURE DATE: 2017-10-03. MEDICAL DEVICE LOT #: 7177895, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30, DEVICE MANUFACTURE DATE: 2017-07-24. DEVICE EVALUATED BY MFR: 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 WAS NOTICED IN THE EYLEA SOLUTION DRAWN UP BY THE BD SYRINGE LUER-LOK¿ TIP DURING USE. LOT #'S 7300853, 7240908, AND 7177895 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PARTICLES/TROUBLE SOLUTION HAS BEEN IDENTIFIED BY THE DOCTOR INTO THE SYRINGE AFTER COLLECTING EYLEA SOLUTION INTO THE VIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548021 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H.10. 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other