BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 ML BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 15329374 · Received August 31, 2022

    Report

    Report Number
    1911916-2022-00463
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    August 1, 2022
    Report Date
    September 2, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903028320
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1145180, MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2026, DEVICE MANUFACTURE DATE: 25-MAY-2021. MEDICAL DEVICE LOT #: 1215164 , MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2026, DEVICE MANUFACTURE DATE: 03-AUG-2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: IT WAS REPORTED SYRINGES HAVE A VERY HIGH RESISTANCE WHEN DRAWING THE PLUNGER OUT OF THE BARREL. TO AID IN THE INVESTIGATION, ELEVEN SAMPLES WITH NO PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE OF THE ELEVEN SAMPLES IS LABELED "CONTROL" AND THE OTHER TEN SAMPLES HAVE A HAND WRITTEN NOTE "STIFF RESISTANCE DRAWN BACK 2X LOT# 1145180 OR 1215164 BD M47213 OR M47761 BIO" BY THE CUSTOMER. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS TESTED FOR BREAK FORCE, WHICH IS THE INITIAL FORCE RECORDED WHEN THE PLUNGER ROD-RUBBER STOPPER STARTS MOVING, AND SUSTAINING FORCE, WHICH IS THE FORCE APPLIED TO THE PLUNGER ROD WHILE MOVING DOWNWARDS WHEN EXPELLING THE SALINE SOLUTION, AND ALL RESULTS WERE WITHIN SPECIFICATION. IT COULD BE POSSIBLE PRODUCTS RECEIVED ARE TOWARDS THE HIGHER SIDE OF SPECIFICATION WHICH COULD INDUCE THE CUSTOMER NOTICING A DIFFERENCE DURING USE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT NUMBER 1145180 AND 1215164. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 60 30 ML BD LUER-LOK¿ TIP SYRINGES EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCTION TEAM HAS REPORTED THAT THEY ARE FINDING SOME OF THE 30 ML BD SYRINGES HAVE A VERY HIGH RESISTANCE WHEN DRAWING THE PLUNGER OUT OF THE BARREL WHEN THEY ARE FILLING THE SYRINGES WITH ONE OF OUR PRODUCTS. THE PRODUCT IS A DILUTE WATER BASED SIMPLE SOLUTION AND WE HAVE CHECKED SEVERAL EMPTY SYRINGES AND THE HIGH RESISTANCE IS CONFIRMED AS DUE TO THE SYRINGE. IT IS INTERMITTENT SO NOT ALL SYRINGES ARE IMPACTED. WE ANTICIPATE THAT WE WILL GET CUSTOMER COMPLAINTS IF WE SUPPLY OUR PRODUCT FILLED INTO THE SYRINGES WITH THE VERY HIGH RESISTANCE AS THE PRODUCT IS ADMINISTERED MANUALLY AND ON PUMP DRIVERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 60 30 ML BD LUER-LOK¿ TIP SYRINGES EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCTION TEAM HAS REPORTED THAT THEY ARE FINDING SOME OF THE 30 ML BD SYRINGES HAVE A VERY HIGH RESISTANCE WHEN DRAWING THE PLUNGER OUT OF THE BARREL WHEN THEY ARE FILLING THE SYRINGES WITH ONE OF OUR PRODUCTS. THE PRODUCT IS A DILUTE WATER BASED SIMPLE SOLUTION AND WE HAVE CHECKED SEVERAL EMPTY SYRINGES AND THE HIGH RESISTANCE IS CONFIRMED AS DUE TO THE SYRINGE. IT IS INTERMITTENT SO NOT ALL SYRINGES ARE IMPACTED. WE ANTICIPATE THAT WE WILL GET CUSTOMER COMPLAINTS IF WE SUPPLY OUR PRODUCT FILLED INTO THE SYRINGES WITH THE VERY HIGH RESISTANCE AS THE PRODUCT IS ADMINISTERED MANUALLY AND ON PUMP DRIVERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2615089 30 ML BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H10 00382903028320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown