BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL S/C 200

    MDR report key: 9286484 · Received November 6, 2019

    Report

    Report Number
    1213809-2019-01116
    Event Type
    Malfunction
    Date Received
    November 6, 2019
    Date of Event
    October 22, 2019
    Report Date
    December 27, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THREE PHOTOS AND FIVE 10ML SYRINGES IN FULLY SEALED BLISTER PACKS FROM BATCH 9170912 (P/N 302995) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THREE OF THE SYRINGES CONTAINED NO SCALE MARKINGS AND WERE REJECTABLE PER PRODUCT SPECIFICATION. MANUFACTURING REVIEW REVEALED ADJUSTMENTS TO MARKER WERE MADE THAT INCLUDED INK MANIFOLD CLEANING. POTENTIAL ROOT CAUSE FOR MISSING PRINT IS ASSOCIATED WITH THE MARKING PROCESS. THERE WAS LIKELY AN INSUFFICIENT INK FLOW TO THE PAD THROUGH THE MANIFOLD RESULTING IN MISSING PRINT OBSERVED. PRODUCT WAS RE-QUALIFIED PER APPLICABLE AQL WHEN THE DEFECT WAS DISCOVERED DURING PRODUCTION. IT IS POSSIBLE THAT NOT ALL PRODUCT WAS CONTAINED AND A LIMITED NUMBER ESCAPED DETECTION. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9170912 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE SYRINGE 10ML LL S/C 200 HAS BEEN FOUND EXPERIENCING FIVE OCCURRENCES OF MISSING SCALE MARKINGS BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SYRINGES HAD NO MARKINGS TO IDENTIFY VOLUME. PER EMAIL: 10ML LL SYRINGE GGH# 0000530 WITH NO MARKINGS TO IDENTIFY VOLUME.

    Additional Manufacturer Narrative · 1

    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 SYRINGE 10ML LL S/C 200 HAS BEEN FOUND EXPERIENCING FIVE OCCURRENCES OF MISSING SCALE MARKINGS BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SYRINGES HAD NO MARKINGS TO IDENTIFY VOLUME. PER EMAIL: 10ML LL SYRINGE GGH# 0000530 WITH NO MARKINGS TO IDENTIFY VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077527 SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9170912 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other