BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7699836 · Received July 18, 2018

    Report

    Report Number
    1710034-2018-00407
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    May 23, 2018
    Report Date
    August 24, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814238
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO. DHR REVIEW WAS CONDUCTED, WHICH DISCLOSED THE FOLLOWING: LOT 8002764; WAS BUILT ON AFA LINE 2 FROM (B)(6) 2018 THROUGH (B)(6) 2018 AND PACKAGED ON PACKAGING LINES 9 AND 9 FROM (B)(6) 2018 THROUGH (B)(6) 2018 FOR THE QUANTITY OF (B)(4). ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SET-UP AND IN PROCESS SAMPLING PLANS. ALL SET-UP AND IN-PROCESS SAMPLES (INCLUDING BUT NOT LIMITED TO DAMAGED COMPONENTS) WERE CONDUCT, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. SAP (QN) DATABASE REVIEW; WAS CONDUCTED FOR THIS MDR-LEVEL A INVESTIGATION WHICH DISCLOSED THAT THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECT ASSOCIATED WITH THE LOT NUMBER PROVIDED FOR THIS INCIDENT. OBSERVATIONS AND TESTING COULD NOT BE CONDUCTED BECAUSE UNITS WERE NOT PROVIDED FOR THIS INCIDENT, THEREFORE THIS INCIDENT IS INDETERMINATE AND THE ALLEGED DEFECT WAS NOT CONFIRMED AND A ROOT CAUSE COULD NOT BE ESTABLISHED CONCLUSION(S): THE ALLEGED DEFECT DESCRIBED IN THE PRODUCT INCIDENT REPORT WAS NOT CONFIRMED OR REPLICATED; AS UNITS WERE NOT PROVIDED FOR THIS INCIDENT, THEREFORE A DEFINITE ROOT CAUSE COULD NOT BE ESTABLISHED. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT CURRENT RISK IS ACCEPTABLE. OCCURRENCE AND SEVERITY RANKINGS HAVE NOT CHANGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING A BD INSYTE AUTOGUARD SHIELDED IV CATHETER, "NURSE NOTICED SLIGHT RESISTANCE WHEN SHE TRIED TO REMOVE IT. WHEN SHE TRIED TO PULL ON IT THE SECOND TIME, THE PIV CAME OUT EASILY BUT THE CATHETER BROKE ABOUT ¼ CM BELOW THE BLUE HUB." THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    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. FDA NOTIFIED?: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON ((B)(6) 2018) VIA MEDWATCH # MW5077686

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN USING A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER, "NURSE NOTICED SLIGHT RESISTANCE WHEN SHE TRIED TO REMOVE IT. WHEN SHE TRIED TO PULL ON IT THE SECOND TIME, THE PIV CAME OUT EASILY BUT THE CATHETER BROKE ABOUT ¼ CM BELOW THE BLUE HUB." THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543332 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8002764 30382903814238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other