BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 11313788 · Received February 11, 2021

    Report

    Report Number
    1213809-2021-00074
    Event Type
    Malfunction
    Date Received
    February 11, 2021
    Date of Event
    January 11, 2021
    Report Date
    March 4, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096572
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 3ML LL 200 S/C EXPERIENCED A PLUNGER THAT WAS LOOSE/FELL OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: UNKNOWN (PROVIDED 191201), UNKNOWN. CUSTOMER REPORTED THAT WITH LITTLE TO NO EFFORT AFTER FILLING THE SYRINGE WITH INSULIN THE PLUNGER CAME OUT CAUSING HER TO SPILL INSULIN ALL OVER HERSELF. NUMBER OF OCCURRENCES [1]. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PRODUCT WITH ISSUE - BD 3ML SYRINGE, PN 309657. PRODUCT LOT # - [191201]. DID ISSUE CAUSE ANY INJURY? NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? NO. RESOLUTION ¿ CALLER SUCCESSFULLY FILLED A CARTRIDGE WITH INSULIN. NO FURTHER TANDEM FOLLOW UP IS REQUIRED.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND THE REPORTED DEFECT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 3ML LL 200 S/C EXPERIENCED A PLUNGER THAT WAS LOOSE/FELL OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: UNKNOWN (PROVIDED 191201), UNKNOWN CUSTOMER REPORTED THAT WITH LITTLE TO NO EFFORT AFTER FILLING THE SYRINGE WITH INSULIN THE PLUNGER CAME OUT CAUSING HER TO SPILL INSULIN ALL OVER HERSELF. NUMBER OF OCCURRENCES - [1]. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO PRODUCT WITH ISSUE - BD 3ML SYRINGE, PN 309657. PRODUCT LOT # - [191201]. DID ISSUE CAUSE ANY INJURY? - NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? - NO. RESOLUTION ¿ CALLER SUCCESSFULLY FILLED A CARTRIDGE WITH INSULIN. NO FURTHER TANDEM FOLLOW UP IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216452 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 00382903096572

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR