BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL

    MDR report key: 7075593 · Received December 1, 2017

    Report

    Report Number
    1710034-2017-00414
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    November 7, 2017
    Report Date
    November 11, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE RETURNED SAMPLE WAS INSPECTED AND THE REPORTED ISSUE WAS CONFIRMED. THE ROOT CAUSE WAS CONCLUDED TO BE NON-FOREIGN AND IDENTIFIED AS PLUG SHAVINGS WHICH RESULTED FROM THE MANUFACTURING DURING THE ASSEMBLY PROCESS. IT IS CONCLUDED THAT THE DEFECTIVE PRODUCT ORIGINATED FROM AN ISOLATED OCCURRENCE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY. INVESTIGATION SUMMARY:THE CORRECTIVE ACTION STATEMENT IS APPROVED/AUTHORIZED AND FINAL REVIEW OF THE COMPLAINT WILL BE CONDUCTED BY DESIGNATED COMPLAINT HANDLING UNIT. REASON: DHR¿S ARE AVAILABLE FOR REVIEWS AS NEEDED AND ARE REQUIRED FOR QUALITY ISSUES RELATING TO PRODUCT TRACEABILITY OR IF THE REPORTED INCIDENT IS A MEDICAL DEVICE REPORTABLE (MDR). FINDINGS: THE LOT WAS BUILT AND PACKAGED ON AFA LINE 11 ON MAR 24, 2017 FOR THE QUANTITY OF (B)(4) EA. REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES AND TESTING WAS CONDUCTED PER SPECIFICATIONS AND IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE EVENT DESCRIPTION. THE PEURA (END USER RISK ANALYSIS): YES REASON: THE PEURA IS REQUIRED FOR ALL MDR REPORTABLE INVESTIGATIONS. FINDINGS: RM5835 REV 11 VERSION I WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT CURRENT RISK IS ACCEPTABLE. OCCURRENCE AND SEVERITY RANKINGS HAVE NOT CHANGED. OBSERVATIONS AND TESTING: RECEIVED ONE USED 22GA BC CATHETER ADAPTER ASSEMBLY AND A NEEDLE COVER WITHIN AN OPEN PACKAGE FROM LOT NUMBER 7080832. VISUAL/MICROSCOPIC EXAMINATION: WHITE/CLEAR MATERIAL WAS PRESENT AT THE TIP OF THE CATHETER TUBING. THE MATERIAL WAS IDENTIFIED TO BE NON-FOREIGN PLUG SHAVINGS. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO, BASED ON THE VISUAL EVALUATION PERFORMED IT WAS OBSERVED A WHITE MATERIAL WAS VISIBLE ON THE CATHETER TUBING. THE MATERIAL WAS IDENTIFIED TO BE NON-FOREIGN (PLUG SHAVINGS). RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: MANUFACTURING COMMENT: THE FM OBSERVED ON THE CATHETER TUBING WAS CONFIRMED TO BE NON-FOREIGN (PLUG SHAVINGS) AND TO HAVE RESULTED FROM MANUFACTURING DURING THE ASSEMBLY PROCESS. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL THERE IS A PIECE OF PLASTIC "HANGING OFF" OF THE CATHETER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853409 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL INTRAVENOUS CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7080832 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other