BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 12422791 · Received September 3, 2021

    Report

    Report Number
    2243072-2021-02236
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 6, 2021
    Report Date
    February 18, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE HUB DISCONNECTED FROM THE BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE DURING USE, AND THE NEEDLE WAS LEFT STUCK IN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HUB BECAME DISCONNECTED FROM THE INTEGRA NEEDLE SYRINGE AND NEEDLE BECAME STUCK IN PATIENT." "WE HAD ANOTHER ISSUE A COUPLE WEEKS BACK WHERE THE HUB BECAME DISCONNECTED FROM THE NEEDLE AND THE NEEDLE BECAME STUCK IN THE PATIENT (WE WERE ABLE TO REMOVE AND THERE WAS NO PATIENT HARM)." D.1. MEDICAL DEVICE BRAND NAME: BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON MEDICAL SYSTEMS (CANAAN) D.4. MEDICAL DEVICE CATALOG #: 305274 D.4. UNIQUE IDENTIFIER (UDI) #: (B)(6)D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: 2/1/2022 G.1. MANUFACTURING LOCATION: BECTON DICKINSON MEDICAL SYSTEMS (CANAAN) G.4. PMA / 510(K)#: K011103 H.6. INVESTIGATION: ONE PICTURE AND ONE SAMPLE OF A 3ML INTEGRA SYRINGE (P/N 305274) WAS RECEIVED AND EVALUATED. THE PICTURE SHOWS AN ACTIVATED INTEGRA SYRINGE WITH A LOOSE GREEN 21X1.5 INCH GAGE NEEDLE NEXT TO IT. THE SAMPLE HAD AN ACTIVATED SYRINGE AND THE NEEDLE WHEN THREADED ONTO THE SYRINGE COULD NOT BE PULLED OFF WITHOUT UNTHREADING IT. THE REPORTED DEFECT CONDITION COULD NOT BE IDENTIFIED. THE REPORTED DEFECT COULD NOT BE CONFIRMED BASED ON THE PHOTO AND SAMPLE RECEIVED AND POTENTIAL ROOT CAUSE COULD NOT BE ESTABLISHED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: AS NO PHYSICAL OR PICTURE SAMPLE, PART NUMBER OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. DHR COULD NOT BE PERFORMED DUE TO UNKNOWN LOT#. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HUB DISCONNECTED FROM THE BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE DURING USE, AND THE NEEDLE WAS LEFT STUCK IN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HUB BECAME DISCONNECTED FROM THE INTEGRA NEEDLE SYRINGE AND NEEDLE BECAME STUCK IN PATIENT." "WE HAD ANOTHER ISSUE A COUPLE WEEKS BACK WHERE THE HUB BECAME DISCONNECTED FROM THE NEEDLE AND THE NEEDLE BECAME STUCK IN THE PATIENT (WE WERE ABLE TO REMOVE AND THERE WAS NO PATIENT HARM)."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HUB DISCONNECTED FROM THE UNSPECIFIED BD INTREGRA¿ SYRINGE WITH NEEDLE DURING USE, AND THE NEEDLE WAS LEFT STUCK IN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HUB BECAME DISCONNECTED FROM THE INTEGRA NEEDLE SYRINGE AND NEEDLE BECAME STUCK IN PATIENT." "WE HAD ANOTHER ISSUE A COUPLE WEEKS BACK WHERE THE HUB BECAME DISCONNECTED FROM THE NEEDLE AND THE NEEDLE BECAME STUCK IN THE PATIENT (WE WERE ABLE TO REMOVE AND THERE WAS NO PATIENT HARM)."

    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. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HUB DISCONNECTED FROM THE UNSPECIFIED BD INTREGRA¿ SYRINGE WITH NEEDLE DURING USE, AND THE NEEDLE WAS LEFT STUCK IN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HUB BECAME DISCONNECTED FROM THE INTEGRA NEEDLE SYRINGE AND NEEDLE BECAME STUCK IN PATIENT." "WE HAD ANOTHER ISSUE A COUPLE WEEKS BACK WHERE THE HUB BECAME DISCONNECTED FROM THE NEEDLE AND THE NEEDLE BECAME STUCK IN THE PATIENT (WE WERE ABLE TO REMOVE AND THERE WAS NO PATIENT HARM)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321022 BD INTREGRA¿ SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown