BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8227444 · Received January 8, 2019

    Report

    Report Number
    1710034-2018-00970
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Date of Event
    December 6, 2018
    Report Date
    March 11, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR REVIEW FOR LOT: 8019501 DHR: LOT WAS BUILT ON AFA LINE 1 FROM 23JAN2018 THROUGH 28JAN2018 AND PACKAGED ON PACKAGING LINE 9 FROM 25JAN2018 THROUGH 19JAN2018 FOR THE QUANTITY OF (B)(4) EA. 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. THERE WERE NO INDICATIONS OF THE ALLEGED DEFECT THROUGHOUT THE BUILD OF THIS LOT, AS THERE WERE NO REJECT FINDINGS THAT WOULD IMPACT UPON THE QUALITY OF THE CATHETERS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. DHR REVIEW FOR LOT 812256 DHR: LOT WAS BUILT ON AFA LINE 1 FROM 02MAY18 THRU 08MAY18 AND PACKAGED ON PKG. LINE 8 FROM 02MAY18 THRU 08MAY18. ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY 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 PIR. CONCLUSION(S): RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE - NO UNITS OR PHOTOS WERE PROVIDED FOR OBSERVATION AND/OR TESTING OF THIS INCIDENT THEREFORE THE ALLEGED DEFECT WAS NOT IDENTIFIED OR CONFIRMED AND A ROOT CAUSE WAS NOT ESTABLISHED. WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT STATED IN THE PIR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS THERE IS A SLOW RETRACTION OF THE CATHETER DURING INSTALLING THE DEVICE.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8019501. MEDICAL DEVICE EXPIRATION DATE: 2020-12-31. DEVICE MANUFACTURE DATE: 2018-01-19. MEDICAL DEVICE LOT #: 8122560. MEDICAL DEVICE EXPIRATION DATE: 2021-04-30. DEVICE MANUFACTURE DATE: 2018-05-02. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS THERE IS A SLOW RETRACTION OF THE CATHETER DURING INSTALLING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21544 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other