BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 ML BD LUER-LOK SYRINGE STERILE, SINGLE USE

    MDR report key: 10860359 · Received November 18, 2020

    Report

    Report Number
    1213809-2020-00812
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 14, 2020
    Report Date
    November 18, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    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

    H.6. INVESTIGATION: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 5 ML BD LUER-LOK¿ SYRINGES STERILE, SINGLE USE EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER REPORTED INSULIN COMING BACK OF SYRINGE NEAR PLUNGER WHEN PULLING INSULIN OUT OF BOTTLE. NUMBER OF OCCURRENCES: 2. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PRODUCT WITH ISSUE - BD 5ML SYRINGE, PN 309646. PRODUCT LOT # - M622291. DID ISSUE CAUSE ANY INJURY? NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? NO. IS PRODUCT MANUFACTURED BY BD? YES. CTS CLARIFICATION LEAKING OF INSULIN CAME OUT OF PLUNGER AREA OF SYRINGE.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 5 ML BD LUER-LOK¿ SYRINGES STERILE, SINGLE USE EXPERIENCED LEAKAGE PAST THE STOPPER/PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ CALLER REPORTED INSULIN COMING BACK OF SYRINGE NEAR PLUNGER WHEN PULLING INSULIN OUT OF BOTTLE ¿ NUMBER OF OCCURRENCES - 2 ¿ DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO ¿ PRODUCT WITH ISSUE - BD 5ML SYRINGE, PN (B)(4) ¿ PRODUCT LOT # - M622291 ¿ DID ISSUE CAUSE ANY INJURY? - NO ¿ DID CUSTOMER REQUIRE MEDICAL INTERVENTION? - NO ¿ IS PRODUCT MANUFACTURED BY BD? - YES. CTS CLARIFICATION LEAKING OF INSULIN CAME OUT OF PLUNGER AREA OF SYRINGE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330584 5 ML BD LUER-LOK SYRINGE STERILE, SINGLE USE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309646 UNKNOWN 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR