BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS

    MDR report key: 11362570 · Received February 22, 2021

    Report

    Report Number
    1920898-2021-00201
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 26, 2021
    Report Date
    April 6, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908411035
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION THE FOLLOWING CODES SHOULD HAVE BEEN PART OF THE SUPPLEMENTAL 1920898-2021-00201 IMDRF ANNEX G GRID: G04019. G04099. IMDRF ANNEX B GRID: B14 . H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7241945. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION NOTED FOR DRY BARRELS. THERE WAS ONE (1) NOTIFICATION NOTED FOR BREAK OUT SUSTAINING H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7241945. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION NOTED FOR DRY BARRELS. THERE WAS ONE (1) NOTIFICATION NOTED FOR BREAK OUT SUSTAINING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS PLUNGER WAS HARD TO MOVE AND THE STOPPER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328411 BATCH NO. 7241945, UNKNOWN. IT WAS REPORTED THAT PLUNGERS ARE HARD TO MOVE AND STOPPERS LOOK DEFORMED. ALSO REPORTED NEEDLES MISSING FROM SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS PLUNGER WAS HARD TO MOVE AND THE STOPPER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328411, BATCH NO. 7241945, UNKNOWN. IT WAS REPORTED THAT PLUNGERS ARE HARD TO MOVE AND STOPPERS LOOK DEFORMED. ALSO REPORTED NEEDLES MISSING FROM SYRINGES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7241945. MEDICAL DEVICE EXPIRATION DATE: NA. DEVICE MANUFACTURE DATE: 2017-10-25. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS PLUNGER WAS HARD TO MOVE AND THE STOPPER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328411 BATCH NO. 7241945, UNKNOWN. IT WAS REPORTED THAT PLUNGERS ARE HARD TO MOVE AND STOPPERS LOOK DEFORMED. ALSO REPORTED NEEDLES MISSING FROM SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258564 SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328411 SEE H.10 00382908411035

    Patients

    Seq Age Sex Outcome Treatment
    1