BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

    MDR report key: 6925626 · Received October 6, 2017

    Report

    Report Number
    1213809-2017-00161
    Event Type
    Malfunction
    Date Received
    October 6, 2017
    Date of Event
    September 7, 2017
    Report Date
    September 27, 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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). INVESTIGATION: DHR REVIEW FOR BATCH #7120875 (P/N 309658): MANUFACTURING DATES: 5/12/2017 ¿ 5/13/2017. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7120875 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: VARIOUS SAMPLES IN THEIR ORIGINAL SEALED PACKAGING RECEIVED AND EVALUATED: - TWO 10ML PLASTIPAK SYRINGES FROM LOT #1706012P (P/N 305959) ¿ NOT CANAAN PRODUCT. - THREE 5ML PLASTIPAK SYRINGES FROM LOT #7086514 (P/N 309649) ¿ CANAAN¿S PRODUCT. - THREE 3ML PLASTIPAK SYRINGES FROM LOT #7120875 (P/N 309658) ¿ CANAAN¿S PRODUCT. - THREE BD ECLIPSE NEEDLES WITH SMARTSLIP FROM LOT #1705003 (P/N 305760) ¿ NOT CANAAN PRODUCT. VISUAL INSPECTION DID NOT REVEAL ANY DEFECTS IN ANY OF THE SAMPLES RECEIVED. A BD ECLIPSE NEEDLE WAS THEN ATTACHED TO DIFFERENT SYRINGE SAMPLES, INCLUDING 10ML, 5ML, AND 3ML. IT WAS OBSERVED THAT WHEN BEING ATTACHED TO THE 3ML SAMPLES, THE HUB TIGHTENED SOONER THAN WHEN ATTACHING TO 5ML OR 10ML SAMPLES. THE CONNECTION WAS STILL SECURE. THERE WAS NO DIFFICULTY CONNECTING THE NEEDLE UP TO THE POINT IT FELT TIGHT FOR ANY OF THE SAMPLES. THE INVESTIGATION DISCOVERED THAT THE LUER COLLAR WAS THE SAME IN ALL OF THE SAMPLES AND HAS NO TAPER. THE DIFFERENCE BETWEEN THE SAMPLES WAS THE SYRINGE TIP, WHICH HAS A TAPER. AN ISO 594/1 RING GAGE TOOL WAS USED TO VERIFY THE TAPER ON ALL OF THE SAMPLES. THE 3ML SAMPLES WERE AT THE LOWER END OF THE RANGE THAN THE 5ML AND 10ML SAMPLES, WHICH MEANS THE 3ML SAMPLES HAVE A SLIGHTLY HIGHER DEGREE OF TAPER ¿ THE TIP WIDENS FASTER. THIS WOULD EXPLAIN THE OBSERVED DIFFERENCE WHEN CONNECTING TO NEEDLE HUBS AND OTHER LUER LOCK DEVICES. THE RESULT WOULD BE THE TIPS ON THE 3ML SYRINGES COMPLETING THE CONNECTION SOONER THAN 5ML OR 10ML USED IN THIS INVESTIGATION. HOWEVER, ALL SAMPLES WERE WITHIN THE SPECIFIED ISO RANGE AND ALL OF THE SAMPLES ARE ACCEPTABLE FOR USE. IT IS NOT RECOMMENDED TO FORCE ANY DEVICES PAST THE POINT OF A SNUG, SECURE CONNECTION. BASED ON THE SAMPLE EVALUATION: UNCONFIRMED: BD CANAAN WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. BASED ON THE FACT THAT NO DEFECT WAS FOUND, CAPA IS NOT REQUIRED AT THIS TIME. UDI#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD 3ML PLASTIPAK¿ SYRINGE LUER-LOK¿ IS DIFFICULT TO CONNECT WITH NEEDLE. THERE IS CONCERN FOR LEAKAGE FROM POOR CONNECTION. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705557 BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7120875

    Patients

    Seq Age Sex Outcome Treatment
    1 Other