BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.5 ML BD MICRO-FINE¿ + INSULIN SYRINGE WITH NEEDLE

    MDR report key: 12173851 · Received July 15, 2021

    Report

    Report Number
    1920898-2021-00759
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    May 23, 2021
    Report Date
    October 20, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-10-19. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (22) 1/2CC, 12.7MM, 29G SYRINGES (2 LOOSE, 20 IN SEALED POLY BAGS) FROM LOT # 9231025. CUSTOMER STATES THAT A COUPLE OF MY SYRINGES HAVE HAD SOME FLUID IN THE BARREL STRAIGHT OUT OF THE PACKAGING AND FLUID LEAKED FROM NEEDLE TIP. ALL RETURNED SYRINGES WERE EXAMINED AND BOTH LOOSE SAMPLES AND 4 OUT OF 20 SAMPLES FROM THE SEALED POLY BAG EXHIBITED A SMALL AMOUNT OF CLEAR LIQUID VISIBLE IN THE BARREL, WHICH COULD COME OUT OF THE CANNULA WHEN FULLY DEPRESSING THE PLUNGER ROD. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231025. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED SEVERAL IMAGES OF A 0.5ML SYRINGE FROM LOT 9231025. THE IMAGES SHOW A BUBBLE AND LIQUID OCCUPYING ABOUT 2 UNITS OF THE SYRINGE. THE LIQUID IS CLEAR AND TRANSPARENT. THERE IS NO EVIDENCE OF THE SYRINGE LEAKING. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231025. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. L2L DISPATCH #77368 WAS OPENED FOR DRY BARRELS. THE PHOTO EYE WAS ADJUSTED TO ALLOW SUFFICIENT SILICONE LUBRICANT TO BE SPRAYED INSIDE OF THE BARREL. WHEN THE PHOTO EYE IS OVERCORRECTED, TOO MUCH SILICONE CAN BE SPRAYED INSIDE THE BARREL CAUSING EXCESSIVE SILICONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 0.5 ML BD MICRO-FINE¿ + INSULIN SYRINGE WITH NEEDLES EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I USE MANY 29G MICROFINE SYRINGES FOR MY TREATMENT. I HAVE FOUND RECENTLY THAT A COUPLE OF MY SYRINGES HAVE HAD SOME FLUID IN THE BARREL STRAIGHT OUT OF THE PACKAGING. AS I DEPRESSED THE PLUNGER TO REMOVE INITIAL AIR FROM SYRINGE THIS FLUID ACTUALLY CAME OUT FROM THE NEEDLE ON ONE OCCASION. IT¿S IS OBVIOUSLY VERY WORRYING WHAT THIS FLUID COULD BE. IT IS A SMALL AMOUNT OF CLEAR FLUID, WHICH LOOKS TO BE MORE VISCOUS THAN WATER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 0.5 ML BD MICRO-FINE¿ + INSULIN SYRINGE WITH NEEDLES EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I USE MANY 29G MICROFINE SYRINGES FOR MY TREATMENT. I HAVE FOUND RECENTLY THAT A COUPLE OF MY SYRINGES HAVE HAD SOME FLUID IN THE BARREL STRAIGHT OUT OF THE PACKAGING. AS I DEPRESSED THE PLUNGER TO REMOVE INITIAL AIR FROM SYRINGE THIS FLUID ACTUALLY CAME OUT FROM THE NEEDLE ON ONE OCCASION. IT¿S IS OBVIOUSLY VERY WORRYING WHAT THIS FLUID COULD BE. IT IS A SMALL AMOUNT OF CLEAR FLUID, WHICH LOOKS TO BE MORE VISCOUS THAN WATER.

    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 3 0.5 ML BD MICRO-FINE¿ + INSULIN SYRINGE WITH NEEDLES EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I USE MANY 29G MICROFINE SYRINGES FOR MY TREATMENT. I HAVE FOUND RECENTLY THAT A COUPLE OF MY SYRINGES HAVE HAD SOME FLUID IN THE BARREL STRAIGHT OUT OF THE PACKAGING. AS I DEPRESSED THE PLUNGER TO REMOVE INITIAL AIR FROM SYRINGE THIS FLUID ACTUALLY CAME OUT FROM THE NEEDLE ON ONE OCCASION. IT¿S IS OBVIOUSLY VERY WORRYING WHAT THIS FLUID COULD BE. IT IS A SMALL AMOUNT OF CLEAR FLUID, WHICH LOOKS TO BE MORE VISCOUS THAN WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072025 0.5 ML BD MICRO-FINE¿ + INSULIN SYRINGE WITH NEEDLE INSULIN SYRINGE W/ NEEDLE FMF BD MEDICAL - DIABETES CARE 9231025

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown