BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON PREVENT® SG GLIDE SAFETY HYPODERMIC NEEDLE

    MDR report key: 14155029 · Received April 20, 2022

    Report

    Report Number
    1213809-2022-00215
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 21, 2022
    Report Date
    April 20, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    10612479248578
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF BIRTH: PATIENT¿S BIRTHDAY WAS NOT PROVIDED, (B)(6) 2021 WAS USED BASED ON AGE OF PATIENT. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWO PHOTOS OF A SAFETYGLIDE 25X1 INCH NEEDLE (P/N 306616) WERE RECEIVED AND EVALUATED. ONE PICTURE SHOWS THE PACKAGE TOP WEB GRAPHICS FACING UP FROM BATCH 1288960. THE OTHER PICTURE HAS AN UNKNOWN SYRINGE ATTACHED TO A 25 GAGE SAFETYGLIDE NEEDLE WITH THE CANNULA MISSING. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR CANNULA PULLED OUT OF HUB DEFECT IS ASSOCIATED WITH THE NEEDLE SUPPLIER¿S MANUFACTURING PROCESS. THE PHOTOS WERE FORWARDED TO THE NEEDLE SUPPLIER FOR FURTHER EVALUATION AND INVESTIGATION. FURTHER INVESTIGATION WAS PERFORMED AT NEEDLE MANUFACTURING SITE. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. POTENTIAL ROOT CAUSE FOR CANNULA PULLED OUT OF HUB DEFECT IS ASSOCIATED WITH ASSEMBLY LINE. A JAM MAY HAVE OCCURRED AT THE CANNULATOR INDUCING THAT INSUFFICIENT EPOXY WAS APPLIED TO THE NEEDLE AND NOT DETECTED IN THE NEXT PROCESSES. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE FLOW OF PRODUCTS WAS GOOD. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A MCKESSON PREVENT® SG GLIDE SAFETY HYPODERMIC NEEDLE THE NEEDLE PULLED OUT OF HUB AND REMAINED IN PATIENTS LEG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1ST OF 3 OCCURRENCES) ON (B)(6) 2022 WE HADE AN (B)(6) OLD COME IN THEIR WELL CHILD VISIT. WHEN THE LAB TEC WAS ADMINISTERING VACCINES, SHE NOTICED WHEN PULLING THE NEEDLE OUT TO DISCARD THE NEEDLE WAS MISSING. WHEN SHE LOOKED DOWN SHE SAW THAT THE NEEDLE WAS INSIDE THE THIGH OF THE PATIENT. THE LAB TECH WAS ABLE TO PUSH THE NEEDLE OUT OF PATIENTS THIGH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A MCKESSON PREVENT® SG GLIDE SAFETY HYPODERMIC NEEDLE THE NEEDLE PULLED OUT OF HUB AND REMAINED IN PATIENTS LEG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1ST OF 3 OCCURRENCES) ON (B)(6)2022 WE HADE AN 8WEEK OLD COME IN THEIR WELL CHILD VISIT. WHEN THE LAB TEC WAS ADMINISTERING VACCINES, SHE NOTICED WHEN PULLING THE NEEDLE OUT TO DISCARD THE NEEDLE WAS MISSING. WHEN SHE LOOKED DOWN SHE SAW THAT THE NEEDLE WAS INSIDE THE THIGH OF THE PATIENT. THE LAB TECH WAS ABLE TO PUSH THE NEEDLE OUT OF PATIENTS THIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266161 MCKESSON PREVENT® SG GLIDE SAFETY HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 192-N251S 1288960 10612479248578

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Unknown