BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 11382448 · Received February 25, 2021

    Report

    Report Number
    1920898-2021-00229
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    February 1, 2021
    Report Date
    March 25, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY CUSTOMER RETURNED (3) 3/10CC, 8MM, 31G RELION SYRINGES IN AN OPEN POLY BAG FROM LOT # 0160001. CUSTOMER STATES THAT THE SYRINGE WOULD NOT DRAW UP INSULIN. ALL RETURNED SYRINGES WERE TESTED AND ALL WERE ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0160001. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL WOULD NOT DRAW UP INSULIN. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328512 BATCH NO. 0160001. IT WAS REPORTED THAT SYRINGE WOULD NOT DRAW UP INSULIN. VERBATIM: RELION PET OWNER REPORTED, HE COULD NOT DRAW INSULIN. STATED, IT "FELT LIKE, NO RESISTANCE WAS THERE".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL WOULD NOT DRAW UP INSULIN. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328512 BATCH NO. 0160001. IT WAS REPORTED THAT SYRINGE WOULD NOT DRAW UP INSULIN. VERBATIM: RELION PET OWNER REPORTED, HE COULD NOT DRAW INSULIN. STATED, IT "FELT LIKE, NO RESISTANCE WAS THERE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277154 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 0160001 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1