BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO¿FINE+ INSULIN SYRINGE

    MDR report key: 7583248 · Received June 8, 2018

    Report

    Report Number
    1920898-2018-00387
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    May 18, 2018
    Report Date
    August 24, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (8) 1/2CC, 8MM, 30G U40 INSULIN SYRINGES IN AN OPEN POLY BAG FROM LOT # 7142850 AND (1) 1/2CC, 8MM, 30G U40 INSULIN SYRINGES IN AN OPEN POLY BAG FROM LOT # 6195894. CUSTOMER STATES THAT ARE POUCHES THAT HAVE BEEN TORN, AND FROM ONE OF THE NEEDLES A DROP OF MOISTURE CAME IN WHEN THE PLUNGER WAS PRESSED. THIS IS LOT NUMBER 6195894 Y (MOISTURE), 7142850 Y (TORN BAGS). THE POLY BAG FOR LOT # 7142850 WAS EXAMINED AND EXHIBITED AN OPEN SEAL ALONG THE BACK OF THE POLY BAG. THE SYRINGE RETURNED IN THE POLY BAG FROM LOT # 6195894 WAS EXAMINED AND NO FOREIGN MATTER WAS OBSERVED IN OR ON THE SAMPLE. HOWEVER, A SMALL CLEAR DROPLET OF MATERIAL CAME OUT THE CANNULA WHEN FULLY DEPRESSING THE PLUNGER ROD. A SMALL PORTION OF THIS MATERIAL WAS REMOVED THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. SEE ATTACHED PHOTOS AND SPECTRA. 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. CAPA # 56537 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# 7142850. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200702334, 200702188] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 6195894. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED ABOUT 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 AND OPEN SEAL). INVESTIGATION CONCLUSION: 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. CAPA # (B)(4) AND SITUATION ANALYSIS # (B)(4) HAVE BEEN OPENED TO ADDRESS THIS ISSUE. POSSIBLE ROOT CAUSE FOR THE OPEN SEAL: AN INADEQUATE SEAL WAS MADE PRIOR TO THE BAG BEING CUT. THIS IS USUALLY BECAUSE OF A MISALIGNMENT ON THE CONVEYOR BELT.

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGES OF THE BD MICRO¿FINE+ INSULIN SYRINGE ARE OPEN/TORN, AND WHEN PRESSING THE PLUNGER A DROP OF MOISTURE CAME "IN". FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGES OF THE BD MICRO¿FINE+ INSULIN SYRINGE ARE OPEN/TORN, AND WHEN PRESSING THE PLUNGER A DROP OF MOISTURE CAME "IN". FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTEVENTION NOTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. "THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7142850; MEDICAL DEVICE EXPIRATION DATE: 06/30/2022; DEVICE MANUFACTURE DATE: 05/22/2017. MEDICAL DEVICE LOT #: 6195894; MEDICAL DEVICE EXPIRATION DATE: 07/31/2021; DEVICE MANUFACTURE DATE: 07/13/2016. 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 PACKAGES OF THE BD MICRO¿FINE+ INSULIN SYRINGE ARE OPEN/TORN, AND WHEN PRESSING THE PLUNGER A DROP OF MOISTURE CAME "IN". FOUND BEFORE USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426541 BD MICRO¿FINE+ INSULIN SYRINGE INSULIN SYRINGE WITH NEEDLE FMF BD MEDICAL - DIABETES CARE SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other