BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8638327 · Received May 23, 2019

    Report

    Report Number
    1710034-2019-00544
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    May 3, 2019
    Report Date
    July 19, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: G.5. PMA/510(K)#: K952861.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS SUBMITTED FOR EVALUATION. OBSERVATIONS REVEALED SLIGHT DAMAGE TO THE INNER RIM AND MINIMAL DAMAGE TO THE OUTER THREAD OF THE INSYTE AUTOGUARD UNIT. THE DAMAGE TO THE INNER RIM OF THE ADAPTER COULD RESULT IN AN UNSECURE CONNECTION/OPEN PATH THAT COULD RESULT IN LEAKAGE IN THE CLINICAL SETTING, HOWEVER THE PHOTOS PROVIDED FOR THIS INCIDENT DID NOT PRESENT SUFFICIENT EVIDENCE TO IDENTIFY OR CONFIRM THE ALLEGED FAILURE OR TO ESTABLISH A DEFINITE ROOT CAUSE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER LEAKED. THIS OCCURRED ON 5 OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USED WITH NIPRO EX-TUBE. DRUG LEAKED FROM THE CONNECTION. THE ISSUE OCCURRED SEVERAL TIMES ON LOT#: 8218966. IT DIDN'T OCCUR ON OTHER LOT. 20190517 ADDITIONAL INFORMATION. THE THREE SAMPLES WILL BE RETURNED FRO EVALUATION. ON 2 EVENTS, SALINE OR GLUCOSE LEAKED, ON THE OTHER EVENT CHEMO HAS BEEN LEAKED FROM THE CONNECTION WITH EX-TUBE. 20190523 THIS PR WAS CREATED FOR THE REQUEST FROM TO SEPARATE COMPLAINT FROM PR#: (B)(4). (B)(4) HAS BEEN SEPARATED TO (B)(4). ON THIS COMPLAINT, CHEMO LEAKAGE WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER LEAKED. THIS OCCURRED ON 5 OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USED WITH NIPRO EX-TUBE. DRUG LEAKED FROM THE CONNECTION. THE ISSUE OCCURRED SEVERAL TIMES ON LOT#8218966. IT DIDN'T OCCUR ON OTHER LOT. 20190517 ADDITIONAL INFORMATION. THE THREE SAMPLES WILL BE RETURNED FRO EVALUATION. ON 2 EVENTS, SALINE OR GLUCOSE LEAKED, ON THE OTHER EVENT CHEMO HAS BEEN LEAKED FROM THE CONNECTION WITH EX-TUBE. 20190523 THIS PR WAS CREATED FOR THE REQUEST FROM ALICIA MARCHEL TO SEPARATE COMPLAINT FROM PR#(B)(4). 941018 HAS BEEN SEPARATED TO 970857, 970861 AND 970865. ON THIS COMPLAINT, CHEMO LEAKAGE WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER LEAKED. THIS OCCURRED ON 5 OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: USED WITH NIPRO EX-TUBE. DRUG LEAKED FROM THE CONNECTION. THE ISSUE OCCURRED SEVERAL TIMES ON LOT#8218966. IT DIDN'T OCCUR ON OTHER LOT. ON 20190517 ADDITIONAL INFORMATION. THE THREE SAMPLES WILL BE RETURNED FRO EVALUATION. ON 2 EVENTS, SALINE OR GLUCOSE LEAKED, ON THE OTHER EVENT CHEMO HAS BEEN LEAKED FROM THE CONNECTION WITH EX-TUBE. ON 20190523 THIS PR WAS CREATED FOR THE REQUEST FROM (B)(6) TO SEPARATE COMPLAINT. (B)(4). ON THIS COMPLAINT, CHEMO LEAKAGE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428359 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8218966 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other