BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH THE BD ULTRA FINENEEDLE

    MDR report key: 12723403 · Received October 29, 2021

    Report

    Report Number
    1920898-2021-01127
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Date of Event
    September 15, 2021
    Report Date
    October 4, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY : EXEC SUMMARY - SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. A REVIEW OF THE COMPLAINT LOT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT FOR FOREIGN MATTER IN SYRINGE ON THIS LOT #. NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. SAMPLES RETURNED - CUSTOMER RETURNED (6) 3/10CC 8MM 31G SYRINGES IN AN OPEN POLYBAG WITH THE SHELF CARTON FROM LOT # 1130991. CUSTOMER STATES THAT A SYRINGE HAS EXCESS SILICONE OIL. ALL RETURNED SYRINGES WERE EXAMINED AND 5 OUT OF 6 SAMPLES EXHIBITED A SMALL, VISIBLE AMOUNT OF LIQUID IN THE BARREL. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM ONE OF THE SAMPLES AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. SAMPLES WILL BE FORWARDED TO MANUFACTURING (HOLDREGE) FOR FURTHER INVESTIGATION. CAPA/SA - BASED ON THE ABOVE INVESTIGATION NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE OR PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) ARE REQUIRED AT THIS TIME. DHR REVIEW - A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 82 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLES HAD FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CUSTOMER REPORTED THROUGH THE PHARMACEUTICALS DISPENSER EXPERIENCING AN ISSUE WITH A SYRINGE HAVING EXCESS SILICONE OIL. THERE WAS NO TYPE OF CUSTOMER OR PATIENT HARM AND THE PARTICULAR SYRINGE WAS DISCARDED AFTERWARDS. DATE OF EVENT : (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618917 BD INSULIN SYRINGES WITH THE BD ULTRA FINENEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1130991

    Patients

    Seq Age Sex Outcome Treatment
    1