BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 9950355 · Received April 10, 2020

    Report

    Report Number
    9614033-2020-00049
    Event Type
    Malfunction
    Date Received
    April 10, 2020
    Date of Event
    February 26, 2020
    Report Date
    April 22, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K151766
    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: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE.. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 3ML LL 200 S/C EXPERIENCED LEAKAGE AT THE CONNECTION SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657, BATCH NO: 8345759. COMPLAINT 1 OF 2.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 3ML LL 200 S/C EXPERIENCED LEAKAGE AT THE CONNECTION SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: 8345759. COMPLAINT 1 OF 2. VERBATIM: DESCRIPTION OF ISSUE: CUSTOMER REPORTED UPON FILLING CARTRIDGE WITH INSULIN, SHE SAW THAT INSULIN WAS SQUIRTING OUT OF CONNECTION BETWEEN NEEDLE AND SYRINGE ON EVENT DATE. NUMBER OF OCCURRENCES: 1. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 4. ITEM NUMBER: 3 ML SYRINGE ¿ 309657, 26 G, 3/8¿ NEEDLE ¿ 305110. PRODUCT LOT NUMBER: NEEDLE: UNAVAILABLE ; SYRINGE: 8345759. FOR BD PRODUCT ONLY, 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? NONE. RESOLUTION: DISTRIBUTOR EXPLAINED THAT BD MIGHT FOLLOW UP WITH CUSTOMER REGARDING RETURNING SYRINGE/NEEDLE. NO FURTHER FOLLOW UP IS REQUIRED. DISTRIBUTOR TO GOODWILL 2PK OF CARTRIDGES. NOTE: PRODUCT CATEGORY = NEEDLE/SYRINGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411060 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 309657 8345759 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other