BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8196493 · Received December 26, 2018

    Report

    Report Number
    1710034-2018-00935
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Date of Event
    December 6, 2018
    Report Date
    February 20, 2019
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DHR DISCLOSED THE FOLLOWING: LOT 8192723; WAS BUILT AND PACKAGED ON AFA LINE 12 ON 13JUL2018 THROUGH 18JUL2018 FOR A TOTAL QUANTITY OF 461,810EA. *ALL CHALLENGE, SET-UP AND IN PROCESS SAMPLES WERE PERFORMED ACCORDING TO THE QUALITY SAMPLING PLANS AND ALL PASSED PER SPECIFICATIONS AND THERE WERE NO INDICATIONS OF THE REPORTED DEFECT DURING BUILD OF THIS LOT. ALTHOUGH UNITS WERE NOT RETURNED, A PHOTO WAS PROVIDED FOR VISUAL EVALUATION OF THIS INCIDENT. PHOTO SHOWED AN UNDAMAGED TOP WEB OF A BLISTER PACK FROM A 22GA BD INSYTE AUTOGUARD BC IV CATHETER, LOT 8192723 AND REF. 382523. PHOTO ALSO SHOWN A USED UNIT WHICH CONSISTED OF THE NEEDLE/HUB ASSEMBLY THAT WAS PARTIALLY RETRACTED WITHIN THE SAFETY SHIELD (BARREL) THAT HAD TRACES OF MEDIA PRESENT. VISUAL/MICROSCOPIC EVALUATION (METHOD ¿ N/A): *OBSERVATIONS OF THE PHOTO PROVIDED FOR THE INCIDENT REVEALED THE BARREL OF THE PARTIALLY RETRACTED UNIT APPEARED TO BE DAMAGED, POSSIBLY SMASHED WITH STRESS MARKS. *WITHOUT THE ACTUAL UNIT FOR OBSERVATION IT COULD NOT BE DETERMINED THE CAUSE OF THE DAMAGE OBSERVED TO THE BARREL, THUS THE PACKAGE DID NOT REVEAL ANY TYPE OF DAMAGE. CONCLUSION(S): RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE - *THE PHOTO PROVIDED FOR THIS INCIDENT DID PRESENT SUFFICIENT EVIDENCE TO IDENTIFY OR CONFIRM THE REPORTED FAILURE, ALTHOUGH THERE WAS NOT SUFFICIENT EVIDENCE TO ESTABLISH A DEFINITE ROOT CAUSE. *WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT. POTENTIAL CONTRIBUTORS: (1)USER ENVIRONMENT; THE DAMAGE TO THE BARREL MAY HAVE RESULTED FROM MISUSE/MISHANDLING OF THE PRODUCT IN THE CLINICAL ENVIRONMENT. (2)MANUFACTURING (PACKAGING PROCESS); THE DAMAGE TO THE BARREL MAY HAVE OCCURRED AT THE AUTOLOADER OF THE PACKAGING PROCESS. ¿THE DAMAGE TO THE BARREL HINDERED A FULL RETRACTION OF THE NEEDLE UPON ACTIVATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER DID NOT RETRACT WHEN THE BUTTON WAS PRESSED AFTER USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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¿ BC SHIELDED IV CATHETER DID NOT RETRACT WHEN THE BUTTON WAS PRESSED AFTER USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036878 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8192723 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other