BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ SYRINGE WITH LUER SLIP CENTRIC TIP

    MDR report key: 8148126 · Received December 10, 2018

    Report

    Report Number
    3002682307-2018-00301
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Date of Event
    November 19, 2018
    Report Date
    January 4, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS FOR REPORTED BATCH 1804263 AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2013 (AUGUST 23RD ¿ 26TH, 2018). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4219, Nº4218, AND Nº4207, IN LOT #8233532 (AUGUST 22ND ¿ 27TH, 2018). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #8233877, #8212968, #8205935, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #8233880, #8212969, #8205937, #8198688 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE STOPPER LOTS #8233883, #8212973, #8205836, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD HAS PERFORMED THE DEAD SPACE TEST FOR THESE 10 PROVIDED SAMPLES, FINDING ALL RESULTS WITHIN SPECIFICATIONS. BD COULD NOT CONFIRM THE REPORTED ISSUE. PRODUCT SPECIFICATIONS FOR BD EMERALD SYRINGES HAVE BEEN DEFINED IN SUCH WAY TO BE IN COMPLIANCE WITH ISO 7886-1 STANDARDS. SPECIFICALLY, THE DEAD SPACE FOR BD EMERALD 2ML SYRINGES IS DEFINED WITH A MAXIMUM VOLUME OF 0,070ML. IN ACCORDANCE, THE PRODUCT DIMENSIONS EFFECTING DEAD SPACE CALCULATIONS (LIKE THE BARREL NOZZLE) HAVE BEEN DESIGNED USING 3D MODELS TO BE IN COMPLIANCE WITH THOSE REQUIREMENTS. BD HAS INSPECTED THE RETURNED SYRINGES FROM THE SAME REPORTED BATCH (1808126) HAVE BEEN TESTED FOR COMPLIANCE WITH DEAD SPACE REQUIREMENTS. THOSE 8 SAMPLES HAVE BEEN TESTED USING METHODOLOGY DESCRIBED IN ISO 7886-1:2017. THE RESULTS ARE SUMMARIZED BELOW: INSPECTED SAMPLES: 10 NON-CONFORMANCES: 0 CONFORMANCES: 10 AVERAGE : 0,042 ML OVERALL STANDARD DEVIATION : 0,0055 ACCORDING TO THE TESTING RESULTS AND EVALUATION OF MANUFACTURING RECORDS, BD CONCLUDES THAT BD EMERALD 2ML SYRINGES MEETS THE APPLICABLE SPECIFICATION FOR DEAD SPACE REQUIREMENTS. CONCLUSION(S): ACCORDING TO THE TESTING RESULTS AND EVALUATION OF MANUFACTURING RECORDS, BD CONCLUDES THAT BD EMERALD 2ML SYRINGES MEETS THE APPLICABLE SPECIFICATION FOR DEAD SPACE REQUIREMENTS. ALTHOUGH A ROOT CAUSE IS NOT ABLE TO BE CLEARLY DETERMINED, A PROBABLE ROOT CAUSE OF THE REPORTED FAILURES DURING TESTING COULD BE ATTRIBUTABLE TO A COMBINATION OF THE FOLLOWING CIRCUMSTANCES: TIGHT TOLERANCES ESTABLISHED FOR THE MAXIMUM DEAD SPACE TOGETHER WITH A MINIMUM NOZZLE DIAMETER ACCORDING TO ISO 7886-1:2017 REQUIREMENTS. VARIABILITY AND SENSITIVITY OF THE OWN TESTING METHODOLOGY FOR DEAD SPACE. AS DESCRIBED IN ISO 7886-1 STANDARD, AFTER EXPELLING THE PURIFIED WATER BY FULLY DEPRESSING THE PLUNGER, THE OUTER SURFACE OF THE SYRINGE SHOULD BE WIPED DRY BEFORE WEIGHT THE SYRINGE. THE VERY LOW TOLERANCES FOR DEAD SPACE WITH THE OWN VARIABILITY OF THE TESTING METHODOLOGY (FORCE APPLIED TO FULLY DEPRESSING THE PLUNGER AND WIPING DRY THE SYRINGE) MAKES IT EASY TO SIGNIFICANTLY INFLUENCE THE FINAL RESULTS.

    Description of Event or Problem · 0

    WAS REPORTED THAT THE SCALE MARKINGS ON THE BD EMERALD¿ SYRINGE WITH LUER SLIP CENTRIC TIP WERE "GROOVED", "CROOKED", AND SUSPECTED TO BE INACCURATE, THUS LEADING TO ISSUES WITH VOLUMETRIC INACCURACY OF MEDICATION WITHDRAWAL.

    Additional Manufacturer Narrative · 1

    (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 THE SCALE MARKINGS ON THE BD EMERALD¿ SYRINGE WITH LUER SLIP CENTRIC TIP WERE "GROOVED", "CROOKED", AND SUSPECTED TO BE INACCURATE, THUS LEADING TO ISSUES WITH VOLUMETRIC INACCURACY OF MEDICATION WITHDRAWAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985122 BD EMERALD¿ SYRINGE WITH LUER SLIP CENTRIC TIP SYRINGE FMF BECTON DICKINSON, S.A. 1808126

    Patients

    Seq Age Sex Outcome Treatment
    1 Other