BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESTEP HUBER NEEDLE SET 20G X 0.75IN WITH Y-SITE

    MDR report key: 9341529 · Received November 19, 2019

    Report

    Report Number
    3006260740-2019-03579
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Date of Event
    October 28, 2019
    Report Date
    December 16, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FPA
    UDI-DI
    00801741066214
    PMA / PMN Number
    K153440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE ANALYSIS, APPLICABLE FMEA DOCUMENTS, APPLICABLE MANUFACTURING RECORDS, AND LABELING. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A HUB LEAK WAS CONFIRMED AND APPEARS TO BE RELATED TO THE USE OF THE DEVICE. THE PRODUCT RETURNED FOR EVALUATION WAS A 20 GA W/Y SITE SAFESTEP INFUSION SET. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH DAMAGE ACCUMULATED THROUGH GRADUAL DEFORMATION DUE TO CONTINUOUS OUTWARD-RADIATING STRESS WITHIN THE LUER HUB ORIFICE, ALSO KNOWN AS MATERIAL CREEP. LIKELY SOURCES OF THE STRESS INCLUDE SLIP-FIT STYLE MALE LUER ADAPTERS SUCH AS THOSE FOUND ON SOME I.V. ADMINISTRATION SETS AND SYRINGES. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND THE CHARACTERISTICS OBSERVED WHICH SUPPORTED THIS TYPE OF FAILURE INCLUDED: THE LUER HUB ORIFICE WAS FOUND TO BE OUT OF ISO TOLERANCE USING A CALIBRATED TAPER GAUGE. USAGE RESIDUE WAS SEEN THROUGHOUT THE SAMPLE. LACK OF MECHANICAL DAMAGE ON THE LUER HUB. ATTACHMENT OF THE DEVICE TO NON-COMPLAINANT LUER-LOCK ADAPTERS WAS UNREMARKABLE . THE EVIDENCE SUGGESTS THAT A TAPERED OBJECT WAS FORCEFULLY INSERTED INTO THE LUER HUB ORIFICE THEN LEFT IN PLACE, RESULTING IN GRADUAL WIDENING, OR CREEP, OF THE LUER HUB MATERIAL. THIS TYPE OF FAILURE WAS REPLICATED AT BAS USING 5 ISO COMPLIANT SLIP-FIT ADAPTERS AND 5 NON-COMPLAINANT INFUSION SETS. A COMBINATION OF USE OF SLIP-FIT STYLE ADAPTERS, THE FORCE WITH WHICH THOSE ADAPTERS WERE INSERTED, AND THE DURATION OF INSERTION RESULTED IN THIS TYPE OF SLOW LUER HUB DEFORMATION. CREEP DEFORMATION TAKES PLACE OVER DAYS; HOWEVER, THE RATE OF DEFORMATION DEPENDS UPON THE FORCE USED TO INSERT THE TAPER. THIS TYPE OF DAMAGE MAY POSSIBLY BE MITIGATED BY REDUCING THE INSERTION FORCE AND/OR USING LUER-LOCK STYLE ADAPTERS. A LOT HISTORY REVIEW (LHR) OF ASDRS0035 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRUG WAS BEING INFUSED THROUGH SIGMA FILTER WHICH WAS CONNECTED TO THE SAFESTEP NEEDLE WHEN A LEAK WAS FOUND AT THE CONNECTION SITE. A B BRAUN 3 WAY WAS USED TO COMPLETE THE DRUG DELIVERY.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF ASDRS0035 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRUG WAS BEING INFUSED THROUGH SIGMA FILTER WHICH WAS CONNECTED TO THE SAFESTEP NEEDLE WHEN A LEAK WAS FOUND AT THE CONNECTION SITE. A B BRAUN 3 WAY WAS USED TO COMPLETE THE DRUG DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136633 SAFESTEP HUBER NEEDLE SET 20G X 0.75IN WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR FPA BARD ACCESS SYSTEMS N/A ASDRS0035 00801741066214

    Patients

    Seq Age Sex Outcome Treatment
    1