BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS

    MDR report key: 8833588 · Received July 26, 2019

    Report

    Report Number
    1920898-2019-00707
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 5, 2019
    Report Date
    September 3, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908418034
    PMA / PMN Number
    K170386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) 1CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 8092823. CUSTOMER STATES THAT IT WAS BENT AND A SIGNIFICANT AMOUNT OF SOME KIND OF SOLUTION CAME OUT OF IT. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A BENT CANNULA. ALSO, NO FOREIGN MATTER WAS OBSERVED INSIDE THE BARREL. HOWEVER, WHEN THE PLUNGER ROD WAS FULLY DEPRESSED, A SMALL CLEAR DROPLET OF MATERIAL CAME OUT OF THE CANNULA. 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 (B)(4) UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8092823. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200753438, 200754193] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200754336] NOTED FOR FM IN BARREL. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. AS PER INVESTIGATION COMPLETED BY MANUFACTURING, "ON 19AUG2019, HOLDREGE RECEIVED (1) 1.0ML,8MM, 31G SYRINGE IN AN OPEN POLYBAG FROM LOT #8092823. SAMPLE WAS DECONTAMINATED PER HSTR-17 AND HQA-68 PRIOR TO EVALUATION. VISUAL INSPECTION OF THE SYRINGE FOUND THE CANNULA BENT AT 15 DEGREE ANGLE AND CONTACT DAMAGE ON THE INSIDE OF THE SHIELD FROM THE CANNULA. THE PLUNGER WAS EXERCISED AND FLUID FORMED ON THE TIP OF THE CANNULA. PER FTIR ANALYSIS PERFORMED AT FLKS, THE FLUID INSIDE THE BARREL WAS IDENTIFIED AS SILICONE. PER TP700361, REV 7, SECTION 9.1 "FORMATION OF DROPLETS" IS EVIDENCE EXCESS SILICONE. THE CANNULA IS INSTALLED IN THE BARREL TIP AT THE CANNULATOR WITH ADHESIVE. THE ADHESIVE IS CURED IN AN UV OVEN BEFORE THE SHIELD IS INSTALLED AT THE SHIELDER ASSEMBLY DIAL. THE BARREL ASSEMBLY HAS SILICONE APPLIED AT THE METRO ASSEMBLY MACHINE. SILICONE IS SPRAYED INTO THE BARREL BEFORE TRANSFERRING TO AN ASSEMBLY DIAL THAT INSTALLS THE PLUNGER ROD. A REVIEW OF QUALITY NOTIFICATIONS FOR LOT #8092823 FOUND NO NOTIFICATIONS RELATED TO THIS COMPLAINT. MAINTENANCE DISPATCHES WERE REVIEWED FOR DATES OF MANUFACTURE AND FOUND NO DISPATCHES RELATED TO THE COMPLAINT. UNABLE TO DETERMINE ROOT CAUSE OF EXCESS SILICONE AND BENT CANNULA. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORT CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED AND TREND ON REPORTS MONITORED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328418, BATCH NO: 8092823. CUSTOMER: I OPENED MY PACKAGE OF INSULIN SYRINGES, & WHEN I TOOK ONE OUT, IT WAS BENT & A SIGNIFICANT AMOUNT OF SOME KIND OF SOLUTION CAME OUT OF IT. I DIDN'T USE THE NEEDLE, AS I WAS WORRIED & A BIT SCARED TO.

    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 AN UNSPECIFIED NUMBER OF SYRINGE 1.0 ML 31GA 8 MM UFII 10BAG 500CS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328418. BATCH NO: 8092823. VERBATIM: I OPENED MY PACKAGE OF INSULIN SYRINGES, & WHEN I TOOK ONE OUT, IT WAS BENT & A SIGNIFICANT AMOUNT OF SOME KIND OF SOLUTION CAME OUT OF IT. I DIDN'T USE THE NEEDLE, AS I WAS WORRIED & A BIT SCARED TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623818 SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8092823 00382908418034

    Patients

    Seq Age Sex Outcome Treatment
    1 Other