BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH NEEDLE

    MDR report key: 12713390 · Received October 28, 2021

    Report

    Report Number
    3002682307-2021-00580
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    August 20, 2021
    Report Date
    November 2, 2021
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2102144. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES WERE OBTAINED. THE RETAINED SAMPLES WERE EVALUATED BY OUR QUALITY ENGINEER TEAM AND NO SIGNS OF DEFECT COULD BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ SYRINGE WITH NEEDLE LEAKED SALINE FROM THE NEEDLE PLUG AFTER ASPIRATING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE BED NURSE PREPARED TO SUCK THE NORMAL SALINE TO FLUSH THE FISTULA NEEDLE FOR THE PATIENT'S FISTULA PUNCTURE. AFTER ASPIRATING THE NORMAL SALINE, PART OF THE SALINE LEAKS FROM THE NEEDLE PLUG. THE SYRINGE IS REPLACED AND THE SALINE IS RE-ASPIRATED."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ SYRINGE WITH NEEDLE LEAKED SALINE FROM THE NEEDLE PLUG AFTER ASPIRATING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE BED NURSE PREPARED TO SUCK THE NORMAL SALINE TO FLUSH THE FISTULA NEEDLE FOR THE PATIENT'S FISTULA PUNCTURE. AFTER ASPIRATING THE NORMAL SALINE, PART OF THE SALINE LEAKS FROM THE NEEDLE PLUG. THE SYRINGE IS REPLACED AND THE SALINE IS RE-ASPIRATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1608463 BD¿ SYRINGE WITH NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2102144

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown