BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 10214283 · Received June 30, 2020

    Report

    Report Number
    3006948883-2020-00263
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    June 10, 2020
    Report Date
    July 15, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (270) 3/10CC, 6MM, 31G SYRINGES (20 IN OPEN POLY BAGS WHERE 4 OF THESE WERE FILLED WITH APPROXIMATELY 7 UNITS OF A LIQUID IN THE BARREL, 250 IN SEALED POLY BAGS) FROM LOT # 9063708. CUSTOMER STATES THAT THE SYRINGE IS CAUSING THE INSULIN TO TURN BLACK. ALL SYRINGES IN THE OPEN POLY BAGS WERE EXAMINED AND 9 OUT OF 20 SAMPLES FROM THE OPEN POLY BAGS AND 12 OUT OF 30 SAMPLES FROM THE SEALED POLY BAGS EXHIBITED SMEARED INK ON THE SURFACE OF THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9063708. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE TWO (2) NOTIFICATIONS [200812519, 200813036] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. PROCESS SUMMARY: PROCESS SUMMARY: THE BARREL PRINTER APPLIES INK FROM A SUBSTRATE TO A MOLDED BARREL THAT HAS BEEN TREATED WITH CORONA TO GET A GOOD ADHESION OF THE INK TO THE MOLDED BARREL. THE BARRELS ARE THEN TRANSITIONED TO THE OVEN FOR THE INK TO CURE. THE CURED PRODUCT EXITS THE OVEN CHUTE FOR TRANSFER TO THE NEXT OPERATION. ROOT CAUSE: DISPATCH (B)(4) ¿ ON 30 APR 2019 FOR WORN OUT PRINTER PADS. CORRECTIVE ACTION: PRINT PADS WERE CHANGED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 SYRINGES 0.3ML 31GA 6MM WHOLE UNIT 10BAG EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:324909, BATCH NO: 9063708. HE DOES NOT RE-USE, ISSUE OCCURRED ON (B)(6) 2020. THE SYRINGE TURNS MY INSULIN BLACK WHEN DRAWN. USED MULTIPLE SYRINGES FROM THIS BAG AND THEY ALL DO IT. THE INSULIN IS NOT BLACK. IT IS CLEAR. NOT GOOD.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 SYRINGES 0.3ML 31GA 6MM WHOLEUNIT 10BAG EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:324909, BATCH NO: 9063708. HE DOES NOT RE-USE, ISSUE OCCURRED ON (B)(6) 2020. THE SYRINGE TURNS MY INSULIN BLACK WHEN DRAWN. USED MULTIPLE SYRINGES FROM THIS BAG AND THEY ALL DO IT. THE INSULIN IS NOT BLACK. IT IS CLEAR. NOT GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680175 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 9063708 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other