BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 18X1-1/2 RB

    MDR report key: 10339905 · Received July 29, 2020

    Report

    Report Number
    1213809-2020-00492
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    July 3, 2020
    Report Date
    August 19, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059189
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/23/2020. H.6. INVESTIGATION: TWO SAFETYGLIDE NEEDLE ASSEMBLIES AND TWO OPENED BLISTER PACKS FROM BATCH 9170953 (P/N 305918) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED VISIBLE LIQUID DROPLETS WERE PRESENT INSIDE THE HUB. NO VISUAL DEFECTS WERE OBSERVED ON EITHER OF THE SAMPLES RECEIVED. THE POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE SAMPLES RECEIVED. NO VISUAL DEFECTS WERE OBSERVED, AND THE SAMPLES WERE MANIPULATED SO LEAKAGE TESTING COULD NOT BE PERFORMED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. DHR WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE SFTYGLD 18X1-1/2 RB EXPERIENCED LEAKAGE AT THE CONNECTION SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT (YYYY-MM-DD): 2020 (B)(6). TYPE OF INCIDENT/PROBLEM: MALFUNCTION - DURING OR AFTER USE. LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE. INCIDENT DETAILS: SOLUTION WAS DRAWN UP INTO A SYRINGE, A NEEDLE WAS ATTACHED AND WHEN THE SOLUTION WAS BEING INJECTED INTO AN IV BAG THE AREA AROUND THE HUB OF THE NEEDLE WAS LEAKING. THE NEEDLE WAS ATTACHED CORRECTLY AND THIS PROBLEM HAPPENED ON MORE THAN ONE OCCASION. WHO WAS AFFECTED? NO PERSON AFFECTED. UNEXPECTED OR PROLONGED CARE? NO. FREQUENCY OF PROBLEM: RECURRING. DEVICE INFORMATION: DEVICE NAME/DESCRIPTION: NEEDLE HYPODERMIC SAFETY GLIDE 18 GAUGE X 1.5 INCH. MANUFACTURER CODE/MODEL: 305918. SERIAL OR LOT NUMBER: 9170953.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE SFTYGLD 18 X 1-1/2 RB EXPERIENCED LEAKAGE AT THE CONNECTION SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2020. TYPE OF INCIDENT/PROBLEM: MALFUNCTION, DURING OR AFTER USE. LEVEL OF HARM: NO EFFECT, DID NOT REACH PATIENT, DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE. INCIDENT DETAILS: SOLUTION WAS DRAWN UP INTO A SYRINGE, A NEEDLE WAS ATTACHED AND WHEN THE SOLUTION WAS BEING INJECTED INTO AN IV BAG THE AREA AROUND THE HUB OF THE NEEDLE WAS LEAKING. THE NEEDLE WAS ATTACHED CORRECTLY AND THIS PROBLEM HAPPENED ON MORE THAN ONE OCCASION. WHO WAS AFFECTED? NO PERSON AFFECTED. UNEXPECTED OR PROLONGED CARE? NO. FREQUENCY OF PROBLEM: RECURRING. DEVICE INFORMATION. DEVICE NAME/DESCRIPTION: NEEDLE HYPODERMIC SAFETY GLIDE 18 GAUGE X 1.5 INCH MANUFACTURER CODE/MODEL: 305918. SERIAL OR LOT NUMBER: 9170953.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806040 NEEDLE SFTYGLD 18X1-1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305918 9170953 30382903059189

    Patients

    Seq Age Sex Outcome Treatment
    1 Other