BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 7878814 · Received September 14, 2018

    Report

    Report Number
    1920898-2018-00714
    Event Type
    Malfunction
    Date Received
    September 14, 2018
    Date of Event
    August 24, 2018
    Report Date
    October 15, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903266319
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) 3/10CC, 12.7MM, 29G SYRINGES (3 IN OPEN POLY BAGS, 7 IN A SEALED POLY BAG) FROM LOT # 7121520. CUSTOMER STATES THAT WATER LIKE FM WAS IN THE BARREL. ALL RETURNED SYRINGES WERE EXAMINED AND 2 OUT OF 3 SAMPLES IN THE OPEN POLY BAGS AND 4 OUT OF 7 SAMPLES IN THE SEALED POLY BAG EXHIBITED A SMALL AMOUNT OF CLEAR LIQUID IN THE BARREL. 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. SAMPLES WERE FORWARDED TO MANUFACTURING (HOLDREGE) ON 21SEP2018 FOR FURTHER REVIEW. ON 25SEP2018, HOLDREGE RECEIVED TEN (10) 0.3ML, 12.7MM, 29G SYRINGES IN OPENED POLYBAGS FROM BATCH # 7121520. ALL SAMPLES ARE DECONTAMINATED PER HSTR-17 PRIOR TO BEING EVALUATED. UPON EVALUATION BY QE AH, SIMILAR FINDINGS TO THOSE DOCUMENTED DURING INITIAL INVESTIGATION PERFORMED AT BD FRANKLIN LAKES WERE NOTED. SAMPLES WERE VISUALLY INSPECTED AND CONFIRMED THE PRESENCE OF SCANT AMOUNTS OF LIQUID WITHIN THE ASSEMBLED SYRINGES. PER FTIR ANALYSIS COMPLETED AT FRANKLIN LAKES, THE LIQUID IS MOST LIKELY SILICONE, A MATERIAL UTILIZED IN THE MANUFACTURING OF SUCH DEVICES. WHILE COSMETICALLY NOT DESIRED BY THE CUSTOMER, THE PRESENCE OF SILICONE IS VITAL TO THE FUNCTIONALITY OF THE PRODUCT. WHEN THIS DEVICE IS OPERATED FOR THE INTENDED USE, GENERALLY, NO HARM TO THE END-USER IS NOTED BY THE PRESENCE OF SILICONE. CAPA (B)(4) AND SITUATION ANALYSIS BDDC-16-871 WERE COMPLETED BY THE HOLDREGE PLANT TO ADDRESS SILICONE POOLING AND ASSOCIATED ROOT CAUSE(S). A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #7121520. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [200696342] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR FOREIGN MATTER IN BARREL ON LOT # 7121520. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED:CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD ULTRA-FINE¿ INSULIN SYRINGE HAD FOREIGN MATTER IN THE BARREL. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    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 A BD ULTRA-FINE¿ INSULIN SYRINGE HAD FOREIGN MATTER IN THE BARREL. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720221 BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7121520 00382903266319

    Patients

    Seq Age Sex Outcome Treatment
    1 Other