BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 2ML EMERALD BNS

    MDR report key: 10411634 · Received August 14, 2020

    Report

    Report Number
    3002682307-2020-00249
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 23, 2020
    Report Date
    September 28, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 8/31/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE LOT NUMBER OF THE RETURNED SAMPLES, LOT: 9317809. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, PHYSICAL SAMPLES AND PICTURE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE RETURNED SAMPLES, NO DEFECTS COULD BE OBSERVED. THE PRODUCT SPECIFICATIONS FOR THE BD EMERALD SYRINGES ARE WITHIN COMPLIANCE STANDARDS AND MEET ALL REGULATORY REQUIREMENTS. ACCORDING TO THE DESCRIBED CIRCUMSTANCES WE ARE NOT ABLE TO ESTABLISH A DIRECT RELATION THAT THE BD EMERALD SYRINGES WOULD HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 2ML EMERALD BNS CAUSED AN IMPURITY PEAK BY INTRODUCING A "SIGNIFICANT CONTAMINANT" INTO THE S-S-S WINDOW OF THE K005 / 3404. THIS WAS NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YESTERDAY I WAS LOOKING AT THE CHROMATOGRAMS OF THE K005 / 3404 AND I COULD NOT PLACE 1 SPECIFIC PEAK IN THE SSS WINDOW. AND I SAW THIS PEAK RECUR IN ALL CHROMATOGRAMS. SINCE I SAW OTHER TYPES OF SYRINGES IN THE STORAGE BIN: GREEN INSTEAD OF BLACK PLUNGERS, I GOT THE SUSPICION THAT THE CAUSE MIGHT BE HERE. I HAVE FILTERED AN ISTD-1 / CH3OH SOLUTION WITH A GREEN AND BLACK SYRINGE IN A GC VIAL AND PRICKED ON GC7 (RESID) CONCLUSION IS THAT: THE GREEN SYRINGES INTRODUCE A SIGNIFICANT CONTAMINANT INTO THE S-S-S WINDOW CORRESPONDING TO A TRIMER CONCENTRATION OF ~ 0.1% ACCORDING TO THE CURRENT CALIBRATION. THE BLACK SYRINGES ARE ALSO NOT FREE FROM CONTAMINANTS. IN THE A-S-S WINDOW YOU WILL ALSO SEE A PEAK (YOU). ALTHOUGH A MUCH SMALLER PEAK AREA THAN THE CONTAMINANT OF THE GREEN SYRINGE. THIS A-S-S CONCENTRATION CORRESPONDS TO A CONCENTRATION OF ~ 0.02% ACCORDING TO THE CURRENT CALIBRATION. WE ALSO SEE A SMALL SHOULDER PEAK IN OUR GPC CHROMATOGRAM, WHICH IS NOT PRESENT WHEN A SAMPLE IS PROCESSED WITH A BLACK SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 2 ML EMERALD BNS CAUSED AN IMPURITY PEAK BY INTRODUCING A "SIGNIFICANT CONTAMINANT" INTO THE S-S-S WINDOW OF THE K005 / 3404. THIS WAS NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YESTERDAY I WAS LOOKING AT THE CHROMATOGRAMS OF THE K005 / 3404 AND I COULD NOT PLACE 1 SPECIFIC PEAK IN THE SSS WINDOW. AND I SAW THIS PEAK RECUR IN ALL CHROMATOGRAMS. SINCE I SAW OTHER TYPES OF SYRINGES IN THE STORAGE BIN: GREEN INSTEAD OF BLACK PLUNGERS, I GOT THE SUSPICION THAT THE CAUSE MIGHT BE HERE. I HAVE FILTERED AN ISTD-1 / CH3OH SOLUTION WITH A GREEN AND BLACK SYRINGE IN A GC VIAL AND PRICKED ON GC7 (RESID) CONCLUSION IS THAT: THE GREEN SYRINGES INTRODUCE A SIGNIFICANT CONTAMINANT INTO THE S-S-S WINDOW CORRESPONDING TO A TRIMER CONCENTRATION OF 0.1% ACCORDING TO THE CURRENT CALIBRATION. THE BLACK SYRINGES ARE ALSO NOT FREE FROM CONTAMINANTS. IN THE A-S-S WINDOW YOU WILL ALSO SEE A PEAK (YOU). ALTHOUGH A MUCH SMALLER PEAK AREA THAN THE CONTAMINANT OF THE GREEN SYRINGE. THIS A-S-S CONCENTRATION CORRESPONDS TO A CONCENTRATION OF 0.02% ACCORDING TO THE CURRENT CALIBRATION. WE ALSO SEE A SMALL SHOULDER PEAK IN OUR GPC CHROMATOGRAM, WHICH IS NOT PRESENT WHEN A SAMPLE IS PROCESSED WITH A BLACK SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870238 SYRINGE 2ML EMERALD BNS PISTON SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other