BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE LUER-LOK¿

    MDR report key: 8024004 · Received October 31, 2018

    Report

    Report Number
    1213809-2018-00725
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 12, 2018
    Report Date
    November 14, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    FOUR PHOTOS WERE RECEIVED AND EVALUATED. THE PHOTOS DEPICT A SINGLE 3ML SYRINGE FROM DIFFERENT SIDES AND ANGLES. THE SYRINGE HAS THE STOPPER BOTTOMED OUT IN 2 OF THE PHOTOS AND STOPPER DRAWN BACK SLIGHTLY WITH CLEAR LIQUID RESIDUE IN FLUID PATH IN 2 OTHER PHOTOS. IN ALL 4 PHOTOS SMALL DROPLETS CAN BE OBSERVED BEHIND THE STOPPER, SIMILAR TO A SPRAY PATTERN. IN 1 PHOTO LIQUID RESIDUE CAN BE SEEN AT THE PLUNGER RETAINING RING IMMEDIATELY BEHIND THE STOPPER. 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. IT IS DIFFICULT TO TELL WHAT THE POTENTIAL ROOT CAUSE FOR THE LEAKAGE PAST STOPPER MAY BE. BASED ON THE DESCRIPTION AND PHOTOS PROVIDED, IT IS NOT POSSIBLE TO DETERMINE A POTENTIAL ROOT CAUSE. A PHYSICAL SAMPLE WOULD BE REQUIRED FOR EVALUATION AND TESTING. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PLASTIPAK SYRINGE LUER-LOK STARTED TO LEAK AT THE PISTON DURING SUCTION. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT #: 8140554, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2018-05-20. (B)(6). 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 A BD PLASTIPAK¿ SYRINGE LUER-LOK¿ STARTED TO LEAK AT THE PISTON DURING SUCTION. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862749 BD PLASTIPAK¿ SYRINGE LUER-LOK¿ PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10. 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other