BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1.0ML 31GA 6MM U40

    MDR report key: 10463458 · Received August 27, 2020

    Report

    Report Number
    1920898-2020-01123
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    August 8, 2020
    Report Date
    October 6, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 10/5/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (19) 1CC, 6MM, 31G U40 INSULIN SYRINGES (9 IN AN OPEN POLY BAG, 10 IN A SEALED POLY BAG) WITH THE SHELF CARTON FROM LOT # 9231170. CUSTOMER STATES THAT THE SYRINGES ARE HARD TO INJECT, THEY ARE VERY TIGHT, AND THEY NEED A LOT OF ENERGY FOR INJECTING WHICH CAUSES PAIN, HARDSHIP AND AT TIMES BLEEDING. ALL RETURNED SYRINGES WERE TESTED (#1-9 FROM THE OPEN POLY BAG, #10-19 FROM THE SEALED POLY BAG) FOR POINT GEOMETRY, LUBE, AND CANNULA OD (SPECS: OUTER DIAMETER FOR 31G: 0.0100¿-0.0105¿). ALL OBSERVATIONS FALL WITHIN SPECIFICATIONS. ALSO, ALL SAMPLES WERE TESTED AND ALL WERE ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. ALL OBSERVATIONS FALL WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231170. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200842457] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION [200841002] NOTED FOR OUT OF SPEC BREAKOUT AND SUSTAINING. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER IS DIFFICULT TO MOVE DURING INJECTION WITH 10 BD SYRINGE 1.0ML 31GA 6MM U40. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSULIN SYRINGES THAT ARE HARD TO INJECT. I HAVE BEEN USING BD INSULIN SYRINGES 31G FOR LONG TIME. BUT OF LATE I AM FINDING QUALITY HAS COME DOWN. THEY ARE VERY TIGHT AND HARD.

    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 THE PLUNGER IS DIFFICULT TO MOVE DURING INJECTION WITH 10 BD SYRINGE 1.0ML 31GA 6MM U40. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSULIN SYRINGES THAT ARE HARD TO INJECT. I HAVE BEEN USING BD INSULIN SYRINGES 31G FOR LONG TIME. BUT OF LATE I AM FINDING QUALITY HAS COME DOWN. THEY ARE VERY TIGHT AND HARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928190 BD SYRINGE 1.0ML 31GA 6MM U40 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9231170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other