BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 10988930 · Received December 10, 2020

    Report

    Report Number
    2243072-2020-02042
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 4, 2020
    Report Date
    November 25, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A 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. PMA/510(K)#: K980987 OR K151766. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE THE CORRECT 510K NUMBER. 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. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. INVESTIGATION CONCLUSION: 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. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 3ML LL 200 S/C NUMBERS WERE SMEARED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657, BATCH NO: UNKNOWN. IT WAS REPORTED THAT SYRINGE NUMBERS LOOK LIKE THERE WAS A MISPRINT AT MANUFACTURING OFF THE SYRINGE, IT ALSO LOOKS LIKE SYRINGE WAS CHEWED UP, AND PLUNGER WILL NOT FULLY PULL UP. EVENT DESCRIPTION PER EMAIL STATES: CALLER REPORTED SYRINGE NUMBERS LOOK LIKE THERE WAS A MISPRINT AT MANUFACTURING OF THE SYRINGE. SYRINGE LOOKS CHEWED UP AND THE PLUNGER WILL NOT FULLY PULL UP. NUMBER OF OCCURRENCES - 1. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO. PRODUCT LOT # - UNAVAILABLE. DID ISSUE CAUSE ANY INJURY? - NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? - NO. IS PRODUCT MANUFACTURED BY BD? - YES, SAMPLE IS AVAILABLE FOR INVESTIGATION. (CONTACT: +1(). RESOLUTION - CTS EXPLAINED THAT BD MIGHT FOLLOW UP WITH CALLER REGARDING RETURNING SYRINGE/NEEDLE. CALLER WAS ABLE TO SUCCESSFULLY FILL A CARTRIDGE. NO FURTHER FOLLOW UP IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454270 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON 309657 UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR