BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL BNS

    MDR report key: 9317016 · Received November 13, 2019

    Report

    Report Number
    1213809-2019-01138
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Date of Event
    October 29, 2019
    Report Date
    December 27, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FOUR PHOTOS EACH DISPLAYING A LOOSE 10ML SYRINGE WERE RECEIVED AND EVALUATED. TWO OF THE SYRINGES IN THE PHOTOS HAD A REJECTABLE AMOUNT OF MISSING PRINT PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING SCALE DEFECT IS COULD NOT BE DETERMINED. IT WAS UNCLEAR FROM THE PHOTOS PROVIDED IF THE PRINT WAS SCRATCHED OFF AT ASSEMBLY OR APPLIED INCORRECTLY AT THE MARKER. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCHES 9080611, 8325855 AND 9080614 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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 WAS REPORTED THAT 67 SYRINGE 10ML LL BNS EXPERIENCED SCALE MARKING ISSUES WHICH WERE NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301029 BATCH NO.: 9080611, 8325855, 9080614. IT WAS REPORTED BLURRY GRADUATION LINES ON THE SYRINGE.

    Additional Manufacturer Narrative · 1

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9080611. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-03-21. MEDICAL DEVICE LOT #: 8325855. MEDICAL DEVICE EXPIRATION DATE: 2023-10-31. DEVICE MANUFACTURE DATE: 2018-11-21. MEDICAL DEVICE LOT #: 9080614. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2019-03-21.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 67 SYRINGE 10ML LL BNS EXPERIENCED SCALE MARKING ISSUES WHICH WERE NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301029 BATCH NO.: 9080611, 8325855, 9080614. IT WAS REPORTED BLURRY GRADUATION LINES ON THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108369 SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other