BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH NEEDLE

    MDR report key: 10311747 · Received July 22, 2020

    Report

    Report Number
    3002682307-2020-00227
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    July 1, 2020
    Report Date
    August 7, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 1901183. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT AND ALL INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE PICTURE SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, LEAKAGE WAS OBSERVED PAST THE PLUNGER ROD COMPONENT. BASED ON THE PROVIDED CUSTOMER FEEDBACK AND THE PICTURE SAMPLE, THIS INCIDENT MOST LIKELY RESULTED FROM DAMAGE TO THE PLUNGER LIP COMPONENT. THIS TYPE OF DAMAGE MAY OCCUR AS THE PRODUCT MOVES THROUGH THE MANUFACTURING PROCESS OR WITHIN THE PLUNGER ASSEMBLY MACHINE. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE BD¿ SYRINGE WITH NEEDLE WHEN OPENING THE HEPARIN CAP. THIS OCCURRED WITH 5 DIFFERENT SYRINGES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "ON (B)(6) 2020, WHEN GOT ON THE MACHINE AND OPENED THE HEPARIN CAP CLAMP FOR PATIENT, AND THE BLOOD RUSHED TO THE SYRINGE."

    Additional Manufacturer Narrative · 1

    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 BLOOD LEAKED FROM THE BD¿ SYRINGE WITH NEEDLE WHEN OPENING THE HEPARIN CAP. THIS OCCURRED WITH 5 DIFFERENT SYRINGES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ON (B)(6) 2020, WHEN GOT ON THE MACHINE AND OPENED THE HEPARIN CAP CLAMP FOR PATIENT, AND THE BLOOD RUSHED TO THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776046 BD SYRINGE WITH NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1901183

    Patients

    Seq Age Sex Outcome Treatment
    1 Other