BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG

    MDR report key: 11720878 · Received April 23, 2021

    Report

    Report Number
    1920898-2021-00458
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 29, 2021
    Report Date
    May 27, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249091
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-04-30 H6: INVESTIGATION SUMMARY CUSTOMER RETURNED SEVEN 0.3ML SYRINGES. NO OTHER IDENTIFICATION WAS PROVIDED. WATER WAS DRAWN INTO EACH OF THE SYRINGES. AFTER WAITING FOR EACH SYRINGE TO FILL WITH WATER, NO AIR BUBBLES WERE NOTED. NONE OF THE SYRINGES WERE FOUND TO BE CLOGGED. LIKEWISE, THE WATER COULD BE PUSHED OUT OF THE SYRINGES WITH NO ISSUES. EACH OF THE RETURNED SYRINGES FUNCTIONS AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0083503 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, BD WAS UNABLE TO REPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF DIFFICULTY DRAWING INSULIN, INDICATED FAILURE OF AIR BUBBLES IN THE SYRINGES. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG WAS DIFFICULT TO ASPIRATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE WILL NOT DRAW AND IT LEAVES AIR BUBBLES IN THE SYRINGE. VERBATIM: CONSUMER REPORTED THAT THE NEEDLE WILL NOT DRAW, LEAVING AIR BUBBLES IN THE SYRINGES.LOT #: 0083503CATALOG #: 324909DATE OF EVENT: UNKNOWNSAMPLES: AVAILABLE - SENDING MAIL KIT".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG WAS DIFFICULT TO ASPIRATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE WILL NOT DRAW AND IT LEAVES AIR BUBBLES IN THE SYRINGE. VERBATIM: CONSUMER REPORTED THAT THE NEEDLE WILL NOT DRAW, LEAVING AIR BUBBLES IN THE SYRINGES. LOT #: 0083503, CATALOG #: 324909, DATE OF EVENT: UNKNOWN, SAMPLES: AVAILABLE - SENDING MAIL KIT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611634 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324909 0083503 00382903249091

    Patients

    Seq Age Sex Outcome Treatment
    1