BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL

    MDR report key: 10103215 · Received May 29, 2020

    Report

    Report Number
    1920898-2020-00588
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    May 14, 2020
    Report Date
    July 1, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: (B)(6) 2020 H.6. INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 1/2CC, 8MM, 31G RELION SYRINGE IN AN OPEN POLY BAG FROM LOT # 9231071. CUSTOMER STATES THAT THERE IS A LITTLE BALL INSIDE THE SYRINGE. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A HARD PIECE OF MATERIAL INSIDE THE BARREL OF THE SYRINGE. 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 POLYPROPYLENE WITH SOME SILICONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231071. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200838188, 200838425] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. PROCESS SUMMARY: THIS AUTOMATIC SYRINGE ASSEMBLY MACHINE FEEDS 0.5ML SYRINGE COMPONENTS (BARREL STOPPER, PLUNGER) AND ASSEMBLES THEM. THIS MACHINE CONSISTS OF A BARREL-CLEANING DIAL, LUBRICATION DIAL, ONE PLUNGER/STOPPER ASSEMBLY DIAL, AND VARIOUS INSPECTION AND TRANSFER DIALS. THERE WERE NO QUALITY NOTIFICATIONS OR LOGBOOK ENTRIES THAT PERTAINED TO THIS COMPLAINT DURING THE PRODUCTION OF THIS BATCH. ROOT CAUSE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE THE SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL HAD FOREIGN MATTER ON THE DEVICE CANNULA/IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER NOTICED WHEN DRAWING UP THE INSULIN THERE WAS A SMALL BALL INSIDE THE SYRINGE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES 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# 9231071. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200838188, 200838425] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE THE SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL HAD FOREIGN MATTER ON THE DEVICE CANNULA/IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER NOTICED WHEN DRAWING UP THE INSULIN THERE WAS A SMALL BALL INSIDE THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567299 SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328509 9231071 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1 Other