BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 6760481 · Received August 2, 2017

    Report

    Report Number
    1213809-2017-00056
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    July 10, 2017
    Report Date
    August 29, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: DHR REVIEW FOR BATCH 6111614 (P/N 309605): MANUFACTURING DATES: 5/27/2016. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. DHR REVIEW FOR BATCH 6146511 (P/N 309605): MANUFACTURING DATES: 6/03/2016 AND 6/16/2016 ¿ 6/17/2016. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. DHR REVIEW FOR BATCH 6146519 (P/N 309605): MANUFACTURING DATES: 6/26/2016. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCHES 6111614, 6146511, 6146519 WERE INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: ONE BOX WITH SAMPLES WAS RECEIVED BY BD CANAAN. THE COMPLAINT REPORTED BATCH # ARE: 6111614, 6146511, 6146519 ALL P/N 309605 ¿ 10ML TRAYS. HOWEVER, INSPECTION OF THE SAMPLES IN THE BOX REVEALED IT CONTAINED MULTIPLE PRODUCTS, SOME IN PLASTIC BAGS, AND OTHERS LOOSE IN THE BOX. THREE OPEN 5ML TRAYS. NO TOP WEB OR SYRINGES IN TRAY ¿ INCORRECT PRODUCT. SEVEN OPEN 5ML TRAYS. NO TOP WEB, BUT EACH TRAY CONTAINED MULTIPLE SYRINGES ¿ INCORRECT PRODUCT. SIX SEALED 10ML TRAYS BATCH # 6300904 ¿ INCORRECT BATCH. ONE PLASTIC BAG CONTAINING 30+ SYRINGES EACH FILLED WITH 3ML UNIDENTIFIED CLEAR LIQUID AND COVERED WITH A PHARMEDIUM LABELED TIP CAPS ¿ NOT EVALUATED. ONE OPEN 10ML TRAY CONTAINING FOUR SYRINGES. NO TOP WEB OR BATCH # IDENTIFICATION. A LARGE STRAND OF HAIR WAS FOUND IN THIS TRAY. NINE OPEN 10ML TRAYS. NO TOP WEB ATTACHED. NO FM FOUND. BASED ON THE EVALUATION OF THE UNMARKED 10ML TRAYS: CONFIRMED: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. HOWEVER, IT IS UNKNOWN WHICH BATCH THIS SAMPLE BELONGED TO. ROOT CAUSE: (1) UNDETERMINED - BASED ON THE INVESTIGATION RESULTS TO DATE, THE SOURCE OF FM COULD NOT BE DETERMINED AND ROOT CAUSE NOT FOUND. CAPA #(B)(4) EXISTS TO INVESTIGATE FM ON THIS MACHINE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE THREE SEPARATE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6146519, MEDICAL DEVICE EXPIRATION DATE: 2021-05-31, DEVICE MANUFACTURE DATE: 2016-06-27. MEDICAL DEVICE LOT #: 6146511, MEDICAL DEVICE EXPIRATION DATE: 2021-05-31, DEVICE MANUFACTURE DATE: 2016-06-24. MEDICAL DEVICE LOT #: 6111614, MEDICAL DEVICE EXPIRATION DATE: 2021-04-30, DEVICE MANUFACTURE DATE: 2016-06-06. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HAIR WAS FOUND INSIDE THE 10 ML BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY. THIS WAS FOUND PRIOR TO USE AND NO MEDICAL INTERVENTIONS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539868 10 ML BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other