BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 20GA 1IN

    MDR report key: 10659134 · Received October 9, 2020

    Report

    Report Number
    1911916-2020-00946
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 17, 2020
    Report Date
    October 14, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051756
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    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: 10/5/2020. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305175 AND LOT NUMBER 8324804. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, FOUR PHYSICAL SAMPLE WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES CAME IN SEALED PACKAGING BLISTERS. EACH WAS VISUALLY INSPECTED WITH AT 10X MAGNIFIER LENS AND NO DAMAGE OR DEFECTS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION AND NO LEAKAGE WAS FOUND. BASED ON THE INVESTIGATION RESULTS, THE SAMPLES RECEIVED DID NOT SHOW THE SYMPTOM REPORTED BY THE CUSTOMER AND AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE 20GA 1IN EXPERIENCED LEAKAGE AT THE CONNECTION SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 2 OF 5 THERE HAD BEEN A FEW INSTANCES WHERE ONE OF MY CLINICS HAVE HAD ISSUES WITH A COUPLE BD PRODUCTS WHEN THEY WERE PERFORMING MEDICATION ADMINISTRATION. IN BOTH INSTANCES MEDICATION SPRAYED OUT OF THE NEEDLE/SYRINGE CONNECTION POINT. BD PRECISION GLIDE NEEDLE 20G X 1¿ PRODUCT # 9872550, LOT # 8324804. IN SEPARATE INSTANCES, MY NURSING TEAM HAS HAD ISSUES WITH THE BD 3ML SYRINGE WHEN THEY WERE DRAWING UP OR ADMINISTERING MEDICATIONS. THE FIRST INSTANCE CAME ABOUT WHEN NURSING STAFF TIGHTENED A BD PRECISIONGLIDE 20G X 1" NEEDLE ONTO A BD 3ML SYRINGE TO DRAW UP MEDICATION TO ADMINISTER TO A PATIENT. WHEN THE NURSE PULLED THE PLUNGER BACK ON THE 3ML SYRINGE THE MEDICATION SPILLED OUT SURROUNDING THE NEEDLE/SYRINGE CONNECTION POINT.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE 20GA 1IN EXPERIENCED LEAKAGE AT THE CONNECTION SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT 2 OF 5 THERE HAD BEEN A FEW INSTANCES WHERE ONE OF MY CLINICS HAVE HAD ISSUES WITH A COUPLE BD PRODUCTS WHEN THEY WERE PERFORMING MEDICATION ADMINISTRATION. IN BOTH INSTANCES MEDICATION SPRAYED OUT OF THE NEEDLE/SYRINGE CONNECTION POINT. BD PRECISION GLIDE NEEDLE 20G X 1¿ PRODUCT # 9872550 LOT # 8324804. IN SEPARATE INSTANCES, MY NURSING TEAM HAS HAD ISSUES WITH THE BD 3ML SYRINGE WHEN THEY WERE DRAWING UP OR ADMINISTERING MEDICATIONS. THE FIRST INSTANCE CAME ABOUT WHEN NURSING STAFF TIGHTENED A BD PRECISIONGLIDE 20G X 1" NEEDLE ONTO A BD 3ML SYRINGE TO DRAW UP MEDICATION TO ADMINISTER TO A PATIENT. WHEN THE NURSE PULLED THE PLUNGER BACK ON THE 3ML SYRINGE THE MEDICATION SPILLED OUT SURROUNDING THE NEEDLE/SYRINGE CONNECTION POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124079 NEEDLE 20GA 1IN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305175 8324804 30382903051756

    Patients

    Seq Age Sex Outcome Treatment
    1 Other