BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ INSYTE AUTOGUARD

    MDR report key: 8199573 · Received December 27, 2018

    Report

    Report Number
    1710034-2018-00932
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    December 6, 2018
    Report Date
    February 13, 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

    H.6. INVESTIGATION SUMMARY: DHR AND SAP (QN) REVIEWS; WERE PREVIOUSLY CONDUCTED FOR INVESTIGATION ((B)(4)) WHICH DISCLOSED THE FOLLOWING: LOT 8192723; WAS BUILT AND PACKAGED ON AFA LINE 12 ON 13JUL2018 THROUGH 18JUL2018 FOR A TOTAL QUANTITY OF (B)(4). 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. SAP (QN): THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE REPORTED DEFECT ASSOCIATED WITH THE LOT NUMBER PROVIDED FOR THIS INCIDENT, AS NO QNS WERE INITIATED FOR THIS LOT. ALTHOUGH UNITS WERE NOT RETURNED, A PHOTO WAS PROVIDED FOR VISUAL EVALUATION OF THIS INCIDENT. PHOTO SHOWS AN UNDAMAGED TOP WEB OF A BLISTER PACK FROM A 22GA BD INSYTE AUTOGUARD BC IV CATHETER, LOT 8192723 AND REF. 382523. PHOTO ALSO SHOWS 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. 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 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 NEEDLES OF BD¿ INSYTE AUTOGUARD DID NOT RETRACT AFTER USE.

    Additional Manufacturer Narrative · 1

    (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 NEEDLES OF BD¿ INSYTE AUTOGUARD DID NOT RETRACT AFTER USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037847 BD¿ INSYTE AUTOGUARD PERIPHERAL VASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8192723 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other