BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION® INSULIN SYRINGE

    MDR report key: 7970608 · Received October 16, 2018

    Report

    Report Number
    1920898-2018-00779
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Date of Event
    September 15, 2018
    Report Date
    November 6, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED 3/10CC, 8MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT # 8043558. CUSTOMER STATES THAT LIQUID CAME OUT OF THE NEEDLE PRIOR TO INJECTION AND PRIOR TO WITHDRAWING INSULIN FROM THE VIAL. BOTH RETURNED SYRINGES WERE EXAMINED AND NO LIQUID OR ANY OTHER FOREIGN MATTER WAS OBSERVED IN OR ON THE SAMPLES. BOTH SAMPLES WERE TESTED AND A SMALL CLEAR DROPLET OF MATERIAL CAME OUT OF THE CANNULA WHEN THE PLUNGER ROD WAS FULLY DEPRESSED. 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. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL. WHEN THE PLUNGER IS FULLY DEPRESSED, THE SILICONE GETS DISTRIBUTED ALONG THE BARREL ROOF AND WALLS, ENSURING A LUBRICATED SURFACE FOR THE PLUNGER TO MOVE AGAINST. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF 25 BILLION UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. CAPA # (B)(4) AND SITUATION ANALYSIS # BDDC-16-871-SA HAVE BEEN OPENED TO ADDRESS THIS ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8043558 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FOUR NOTIFICATIONS [200745136, 200745060, 200745435, 200747137] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (EXCESS SILICONE). POSSIBLE ROOT CAUSES FOR EXCESS SILICONE INCLUDE: THE FIRST IS THAT SOME ASSOCIATES DO NOT DEGAS THE SILICONE AFTER REFILLING THE TANKS. SECOND, THE SILICONE VOLUME ON THE PUMP IS A PARAMETER THAT IS BEING ADJUSTED, BUT IS NOT UNDERSTOOD AND COULD BE A POTENTIAL KPIV.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE RELION® INSULIN SYRINGE LIQUID CAME OUT OF THE NEEDLE PRIOR TO INJECTION AND PRIOR TO WITHDRAWING THE INSULIN FROM THE VIAL. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY : NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8043558 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. INVESTIGATION CONCLUSION : BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED ROOT CAUSE DESCRIPTION : ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE : BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE RELION® INSULIN SYRINGE LIQUID CAME OUT OF THE NEEDLE PRIOR TO INJECTION AND PRIOR TO WITHDRAWING THE INSULIN FROM THE VIAL. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808913 RELION® INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8043558 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Other