BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL BNS

    MDR report key: 8966865 · Received September 5, 2019

    Report

    Report Number
    1911916-2019-00916
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Date of Event
    August 19, 2019
    Report Date
    September 18, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO HAVE BEEN INVOLVED, BUT WERE NOT CONFIRMED BY THE CUSTOMER. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 8332873; D.4. MEDICAL DEVICE EXPIRATION DATE: 11/30/2023; H.4. DEVICE MANUFACTURE DATE: 11/28/2018. D.4. MEDICAL DEVICE LOT #: 9056751; D.4. MEDICAL DEVICE EXPIRATION DATE: 2/29/2024; H.4. DEVICE MANUFACTURE DATE: 2/25/2019. D.4. MEDICAL DEVICE LOT #: 9056754; D.4. MEDICAL DEVICE EXPIRATION DATE: 2/29/2024; H.4. DEVICE MANUFACTURE DATE: 2/25/2019. D.4. MEDICAL DEVICE LOT #: 9056756; D.4. MEDICAL DEVICE EXPIRATION DATE: 2/29/2024; H.4. DEVICE MANUFACTURE DATE: 2/25/2019. D.4. MEDICAL DEVICE LOT #: 9085687; D.4. MEDICAL DEVICE EXPIRATION DATE: 3/31/2024; H.4. DEVICE MANUFACTURE DATE: 3/26/2019. D.4. MEDICAL DEVICE LOT #: 9120958; D.4. MEDICAL DEVICE EXPIRATION DATE: 4/30/2024; H.4. DEVICE MANUFACTURE DATE: 4/30/2019. H.6. INVESTIGATION SUMMARY: ONE (1) PHOTO WAS PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE PHOTO SHOWS TWO (2) SYRINGES NEXT TO EACH OTHER. THERE APPEARS TO BE A PIECE OF BLACK FOREIGN MATTER IN OR ON THE SYRINGE NEAR THE FLANGE OF ONE OF THE SYRINGES. THERE ALSO APPEARS TO BE TAPE ON BOTH SYRINGES WITH BLACK SPOTS ON OR UNDER THE TAPE. FURTHERMORE, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCHES ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. WITHOUT A PHYSICAL SAMPLE TO ANALYZE THE FOREIGN MATTER (FM) THAT APPEARS TO BE IN OR ON THE SYRINGE NEAR THE FLANGE OR ON THE BARRELS UNDER THE TAPE CANNOT BE IDENTIFIED; THEREFORE, POTENTIAL ROOT CAUSES CANNOT BE DETERMINED. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE SYRINGE 30ML LL BNS HAS BEEN FOUND EXPERIENCING 95 OCCURRENCES OF CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301033; BATCH NO. UNKNOWN. IT WAS REPORTED 95 OUT OF 788 SYRINGES INSPECTED WERE FOUND THAT HAD SOME TYPE OF LOOSE PARTICULATE. 301033 -SYR, 30CC L/L - 95 OUT OF 788 FOUND TO HAVE LOOSE PARTICULATE. EMAIL VERBATIM: AS PART OF OUR CONTINUOUS IMPROVEMENT ACTIVITIES, WE HAVE UNDERTAKEN AN EXTENSIVE VISUAL EVALUATION OF INCOMING COMPONENTS TO CHARACTERIZE POSSIBLE SOURCE OF FOREIGN MATERIAL. THE TABLE BELOW HIGHLIGHTS THE RESULTS OF THAT INSPECTION FOR BECTON DICKINSON AND CO ITEMS THAT WERE EVALUATED. BD PART # INTERNAL AVID# DESCRIPTION TOTAL LOOSE: # INSPECTED PERCENTAGE: 301033, 500609, SYR, 30CC L/L, 95, 788, 12.1%.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE SYRINGE 30ML LL BNS HAS BEEN FOUND EXPERIENCING 95 OCCURRENCES OF CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 301033 BATCH NO. UNKNOWN IT WAS REPORTED 95 OUT OF 788 SYRINGES INSPECTED WERE FOUND THAT HAD SOME TYPE OF LOOSE PARTICULATE. 301033 -SYR, 30CC L/L - 95 OUT OF 788 FOUND TO HAVE LOOSE PARTICULATE. EMAIL VERBATIM: AS PART OF OUR CONTINUOUS IMPROVEMENT ACTIVITIES, WE HAVE UNDERTAKEN AN EXTENSIVE VISUAL EVALUATION OF INCOMING COMPONENTS TO CHARACTERIZE POSSIBLE SOURCE OF FOREIGN MATERIAL. THE TABLE BELOW HIGHLIGHTS THE RESULTS OF THAT INSPECTION FOR BECTON DICKINSON AND CO ITEMS THAT WERE EVALUATED. BD PART # 301033, INTERNAL AVID# 500609, DESCRIPTION: SYR, 30CC L/L, TOTAL LOOSE: 95, # INSPECTED: 788, PERCENTAGE: 12.1%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761424 SYRINGE 30ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON AND COMPANY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other