BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 9473968 · Received December 16, 2019

    Report

    Report Number
    1213809-2019-01268
    Event Type
    Injury
    Date Received
    December 16, 2019
    Date of Event
    November 20, 2019
    Report Date
    January 7, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A STAFF MEMBER RECEIVED A DIRTY NEEDLE STICK INJURY FROM THE BD SAFETYGLIDE¿ NEEDLE WHEN ATTEMPTING TO PUSH THE SAFETY "TOO FAST", CAUSING HER FINGER TO SLIP AND STICK ON THE NEEDLE. ADDITIONALLY, IT WAS REPORTED THAT TWO OTHER INCIDENTS OF DIRTY NEEDLE STICK INJURIES OCCURRED DUE TO "PATIENT REACTIONS TO THE INJECTIONS" BY "PULLING AWAY/FLINCHING", CAUSING THE STAFF MEMBER TO STICK THEMSELVES. ALL INCIDENTS OCCURRED DURING USE. LOT#'S 9232458 AND AN UNSPECIFIED LOT WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE UNFORTUNATELY HAD A FEW NEEDLES STICKS OVER THE PAST TWO MONTHS WHEN THE STAFF ARE USING THE BD SAFETY GLIDE NEEDLES." "1 INCIDENT THE MA TRIED TO PUSH THE SAFETY TOO FAST CAUSING HER TO SLIP AND STICK HER FINGER. 2 INCIDENTS WERE PATIENT REACTIONS TO THE INJECTIONS (PULLING AWAY/FLINCHING) CAUSING THE MA TO STICK THEMSELVES".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9232458, MEDICAL DEVICE EXPIRATION DATE: 2024-08-31, DEVICE MANUFACTURE DATE: 2019-08-20. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. 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 A STAFF MEMBER RECEIVED A DIRTY NEEDLE STICK INJURY FROM THE BD SAFETYGLIDE¿ NEEDLE WHEN ATTEMPTING TO PUSH THE SAFETY "TOO FAST", CAUSING HER FINGER TO SLIP AND STICK ON THE NEEDLE. ADDITIONALLY, IT WAS REPORTED THAT TWO OTHER INCIDENTS OF DIRTY NEEDLE STICK INJURIES OCCURRED DUE TO "PATIENT REACTIONS TO THE INJECTIONS" BY "PULLING AWAY/FLINCHING", CAUSING THE STAFF MEMBER TO STICK THEMSELVES. ALL INCIDENTS OCCURRED DURING USE. LOT #'S 9232458 AND AN UNSPECIFIED LOT WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE UNFORTUNATELY HAD A FEW NEEDLES STICKS OVER THE PAST TWO MONTHS WHEN THE STAFF ARE USING THE BD SAFETY GLIDE NEEDLES." "1 INCIDENT THE MA TRIED TO PUSH THE SAFETY TOO FAST CAUSING HER TO SLIP AND STICK HER FINGER. 2 INCIDENTS WERE PATIENT REACTIONS TO THE INJECTIONS (PULLING AWAY/FLINCHING) CAUSING THE MA TO STICK THEMSELVES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271610 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H.10. 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention