BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 8470155 · Received April 1, 2019

    Report

    Report Number
    2243072-2019-00619
    Event Type
    Malfunction
    Date Received
    April 1, 2019
    Date of Event
    February 4, 2019
    Report Date
    April 24, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    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 SUMMARY: TWO SAMPLES WERE RECEIVED. THE SAMPLES WERE RECEIVED WITHOUT PACKAGE, WITH NEEDLE ATTACHED, AND THEY APPEAR TO BE USED SINCE THERE IS A CLEAR LIQUID IN THE FLUID PATH OF THE SYRINGES. NO DEFECTS WERE OBSERVED ON THE TWO SAMPLES RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. NO DEFECT CONFIRMED BASED ON SAMPLES RECEIVED. THEREFORE, NO ROOT CAUSE IDENTIFIED. NO CORRECTIVE ACTIONS RECOMMENDED SINCE NO PRODUCT DEFECTS WERE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS LEAKAGE WITH 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP WHERE THE NEEDLE AND SYRINGE CONNECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. DESCRIPTION OF ISSUE: CUSTOMER REPORTS THAT INSULIN WAS LEAKING OUT OF THE SYRINGE AT THE PART WHERE IT CONNECTS TO THE NEEDLE. 2. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 3. WHAT WAS YOUR BG READING AT THE TIME OF THIS EVENT? 120MG/DL. IF BG BETWEEN 54-500, NO MORE BG QUESTIONS NEEDED.WAS CUSTOMER ABLE TO LOAD A NEW CARTRIDGE? YES. 3. NUMBER OF OCCURRENCES: 1. 4. ITEM NUMBER 3 ML SYRINGE ¿ 309657. 5. PRODUCT LOT NUMBER: M156551 (FROM CARTRIDGE BOX, CUSTOMER UNABLE TO PROVIDE SYRINGE LOT #). 6. ARE SAMPLES AVAILABLE FOR INVESTIGATION?O YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)? YES. 7. DID ISSUE CAUSE ANY INJURY? IF YES, WHAT TYPE OF INJURY? NO. 8. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO. 9. RESOLUTION: CTS EXPLAINED THAT BD MIGHT FOLLOW UP WITH CUSTOMER REGARDING RETURNING SYRINGE/NEEDLE. NO FURTHER TANDEM FOLLOW UP IS REQUIRED. 10. NOTE: PRODUCT CATEGORY = NEEDLE/SYRINGE ISSUE."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER PHONE #: UNKNOWN. PMA / 510(K)#: K980987 OR K151766. DEVICE EVALUATED BY MFR: A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS LEAKAGE WITH 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP WHERE THE NEEDLE AND SYRINGE CONNECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DESCRIPTION OF ISSUE: CUSTOMER REPORTS THAT INSULIN WAS LEAKING OUT OF THE SYRINGE AT THE PART WHERE IT CONNECTS TO THE NEEDLE. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 3. WHAT WAS YOUR BG READING AT THE TIME OF THIS EVENT? 120MG/DL? IF BG BETWEEN 54-500, NO MORE BG QUESTIONS NEEDED. WAS CUSTOMER ABLE TO LOAD A NEW CARTRIDGE? YES. NUMBER OF OCCURRENCES: 1. ITEM NUMBER 3 ML SYRINGE ¿ 309657. PRODUCT LOT NUMBER: M156551 (FROM CARTRIDGE BOX, CUSTOMER UNABLE TO PROVIDE SYRINGE LOT #). ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)? YES. DID ISSUE CAUSE ANY INJURY? IF YES, WHAT TYPE OF INJURY? NO. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO. RESOLUTION: CTS EXPLAINED THAT BD MIGHT FOLLOW UP WITH CUSTOMER REGARDING RETURNING SYRINGE/NEEDLE. NO FURTHER TANDEM FOLLOW UP IS REQUIRED. NOTE: PRODUCT CATEGORY = NEEDLE/SYRINGE ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265134 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other