BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL EURO 200 S/C

    MDR report key: 9412109 · Received December 4, 2019

    Report

    Report Number
    1213809-2019-01217
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    November 19, 2019
    Report Date
    December 11, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE PHOTO OF A LOOSE 3ML SYRINGE WAS RECEIVED AND EVALUATED. NO DEFECTS WERE OBSERVED. THE BLACK DOTS NEXT TO THE BD LOGO OR GRAD LINES ARE USED TO MONITOR THE ETCHINGS ON THE PRINT CYLINDER AND ARE PART OF THE PRINTED SCALE MARKING IMAGE. THESE DOTS ARE THERE BY DESIGN AND ARE NOT DEFECTS. A PRINTED IMAGE MAY HAVE ONE, TWO OR NO DOTS THAT ARE PRINTED ALONG WITH THE SCALE MARKINGS, THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 3ML LL EURO 200 S/C HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WE HAVE AN ISSUE WITH 3ML BD LUER LOCK SYRINGES, MANY OF THE SYRINGES HAVE BLACK DOTS ON THEM. THIS HAS LED TO FINAL PRODUCTS BEING FAILED, CAUSING WASTAGE/COSTS. ALL OUR STOCKS HAVE SOME SYRINGES WITH BLACK DOTS IN EACH BOX, NOT ALL SO WE HAVE SEPARATED. BATCHES IN STOCK 8011570, 7116596, 7338531, 9008912, 9025594.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8011570. MEDICAL DEVICE EXPIRATION DATE: 2022-12-31. DEVICE MANUFACTURE DATE: 2018-01-11. MEDICAL DEVICE LOT #: 7116596. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2017-04-26. MEDICAL DEVICE LOT #: 7338531. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. DEVICE MANUFACTURE DATE: 2017-12-04. MEDICAL DEVICE LOT #: 9008912. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. DEVICE MANUFACTURE DATE: 2019-01-08. MEDICAL DEVICE LOT #: 9025594. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. DEVICE MANUFACTURE DATE: 2019-01-25. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 3ML LL EURO 200 S/C HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WE HAVE AN ISSUE WITH 3ML BD LUER LOCK SYRINGES, MANY OF THE SYRINGES HAVE BLACK DOTS ON THEM. THIS HAS LED TO FINAL PRODUCTS BEING FAILED, CAUSING WASTAGE/COSTS. ALL OUR STOCKS HAVE SOME SYRINGES WITH BLACK DOTS IN EACH BOX, NOT ALL SO WE HAVE SEPARATED. BATCHES IN STOCK 8011570, 7116596, 7338531, 9008912, 9025594.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208843 BD SYRINGE 3ML LL EURO 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309658 SEE H.10 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other