BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 8509159 · Received April 12, 2019

    Report

    Report Number
    1213809-2019-00433
    Event Type
    Malfunction
    Date Received
    April 12, 2019
    Date of Event
    March 28, 2019
    Report Date
    May 8, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903097037
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THREE PHOTOS WERE RECEIVED FOR INVESTIGATION. PHOTOS DEPICTED THAT THE LABEL ON THE OUTSIDE OF THE CASE CARTON WAS CONFIRMED TO BE FROM BATCH# 8285697 AND TRAYS INSIDE THE CASE CARTON WERE LABELED AS INCORRECT BATCH# 8280697. THE BATCH NUMBER WAS INCORRECT ON THE TOP WEB AND NO REJECTIONS WERE NOTED DUE TO HUMAN ERROR DURING INSPECTION. QUALITY NOTIFICATION WAS LATER IDENTIFIED WHICH MOST LIKELY CONTRIBUTED TO THE REPORTED CONDITION. ADDITIONAL INSPECTION PERFORMED AND THE BATCH WAS RELEASED BASED ON MEETING OUR RE-QUALIFICATION REQUIREMENT. ROOT CAUSE: SOFTWARE BUG WITH THE VARIABLE PRINTER AND DUE TO HUMAN ERROR DURING INSPECTIONS. PREVENTIVE AND CORRECTIVE ACTION, CAPA#900946, HAVE BEEN INITIATED TO INVESTIGATE THIS REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 321 SYRINGE 5ML LL TIP BULK CONVENIENCE PAK EXPERIENCED INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: MATERIAL NO.: 309703 BATCH NO.: 8285697. IT WAS REPORTED THAT THE LOT NUMBER DISPLAYED ON THE OUTER BOX DOES NOT MATCH THAT OF THE SYRINGE PACKAGE AND COA. PER EMAIL: OUR DAYTON FACILITY HAS DISCOVERED A DISCREPANCY IN A LOT OF 5ML BD SYRINGES (BD309703). THE LOT NUMBER ON THE OUTER BOX IS LISTED AS 8285697, BUT THE ACTUAL TRAYS HAVE A LOT NUMBER 8280697. BECAUSE THE LOT INFORMATION ON THE BOXES DO NOT MATCH THE LOT NUMBER ON THE PHYSICAL ITEMS WE ARE NOT ABLE TO USE 96,300 SYRINGES/321 CASES DUE TO INTERNAL QUALITY AND COMPLIANCE BREACHES. AS A RESULT, WE ARE ON PACE TO RUN OUT OF 5ML SYRINGE STOCK TOMORROW.

    Additional Manufacturer Narrative · 1

    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 321 SYRINGE 5ML LL TIP BULK CONVENIENCE PAK EXPERIENCED INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: MATERIAL NO.: 309703, BATCH NO.: 8285697. IT WAS REPORTED THAT THE LOT NUMBER DISPLAYED ON THE OUTER BOX DOES NOT MATCH THAT OF THE SYRINGE PACKAGE AND COA. PER EMAIL: OUR (B)(6) FACILITY HAS DISCOVERED A DISCREPANCY IN A LOT OF 5ML BD SYRINGES (BD309703). THE LOT NUMBER ON THE OUTER BOX IS LISTED AS 8285697, BUT THE ACTUAL TRAYS HAVE A LOT NUMBER 8280697. BECAUSE THE LOT INFORMATION ON THE BOXES DO NOT MATCH THE LOT NUMBER ON THE PHYSICAL ITEMS WE ARE NOT ABLE TO USE (B)(4) DUE TO INTERNAL QUALITY AND COMPLIANCE BREACHES. AS A RESULT, WE ARE ON PACE TO RUN OUT OF 5ML SYRINGE STOCK TOMORROW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304998 SYRINGE 5ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8285697 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other