BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 25X1 RB MCK

    MDR report key: 11952807 · Received June 7, 2021

    Report

    Report Number
    1213809-2021-00405
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 16, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    10612479248578
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-06-02. INVESTIGATION SUMMARY: ONE SHELF CARTON WAS RECEIVED CONTAINING FIFTY SEALED PACKAGES IN STRIPS OF FIVE WITH SAFETYGLIDE NEEDLES (P/N 306616) FROM BATCH NUMBER 0141234. THE SAMPLES WERE VISUALLY EVALUATED. THERE WERE NO VISIBLE DEFECTS OBSERVED AND EACH SAMPLE'S SAFETYGLIDE MECHANISM OPERATED AS EXPECTED. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 NEEDLE SFTYGLD 25X1 RB MCK EXPERIENCED DIFFICULTY ENGAGING SAFETY MECHANISM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306616. BATCH NO.: 0141234. ONE NEEDLE BENT DURING USE FOR ONE STAFF MEMBER. THEY SAID THE PATIENT JUMPED A LITTLE BIT WHEN THE INJECTION WAS GIVEN BUT NOT TO THE EXTENT WHERE THEY WOULD EXPECT THE NEEDLE TO BEND AS MUCH AS IT DID. WE HAVE HAD AT LEAST 4 STAFF MEMBERS THAT HAVE BEEN CONCERNED ABOUT THE NEEDLES SINCE THE NEW PACKAGING/DESIGN-WE FEEL THAT THE SAFETY LATCH IS HARD TO ACTIVATE (OFTEN REQUIRING A TWO-HANDED APPROACH) AND IT'S NOT EASY TO TELL IF IT LOCKS INTO PLACE WHICH HAS BEEN VERY CONCERNING. ONE OF OUR STAFF WAS GIVING AN INJECTION THE OTHER DAY AND THE NEEDLE BENT WHILE IN THE PATIENT'S ARM. THE PATIENT HAD JUMPED BUT NOT TO THE POINT WHERE THE STAFF MEMBER WOULD HAVE EXPECTED THE NEEDLE TO BEND AT ALMOST A 90 DEGREE ANGLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 4 NEEDLE SFTYGLD 25X1 RB MCK EXPERIENCED DIFFICULTY ENGAGING SAFETY MECHANISM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306616. BATCH NO.: 0141234. ONE NEEDLE BENT DURING USE FOR ONE STAFF MEMBER. THEY SAID THE PATIENT JUMPED A LITTLE BIT WHEN THE INJECTION WAS GIVEN BUT NOT TO THE EXTENT WHERE THEY WOULD EXPECT THE NEEDLE TO BEND AS MUCH AS IT DID. WE HAVE HAD AT LEAST 4 STAFF MEMBERS THAT HAVE BEEN CONCERNED ABOUT THE NEEDLES SINCE THE NEW PACKAGING/DESIGN-WE FEEL THAT THE SAFETY LATCH IS HARD TO ACTIVATE (OFTEN REQUIRING A TWO-HANDED APPROACH) AND IT'S NOT EASY TO TELL IF IT LOCKS INTO PLACE WHICH HAS BEEN VERY CONCERNING. ONE OF OUR STAFF WAS GIVING AN INJECTION THE OTHER DAY AND THE NEEDLE BENT WHILE IN THE PATIENT'S ARM. THE PATIENT HAD JUMPED BUT NOT TO THE POINT WHERE THE STAFF MEMBER WOULD HAVE EXPECTED THE NEEDLE TO BEND AT ALMOST A 90 DEGREE ANGLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849766 NEEDLE SFTYGLD 25X1 RB MCK NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 192-N251S 0141234 10612479248578

    Patients

    Seq Age Sex Outcome Treatment
    1