BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 9299145 · Received November 8, 2019

    Report

    Report Number
    1710034-2019-01207
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 14, 2019
    Report Date
    December 13, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. PHOTO: THE PHOTO SHOWN CATHETER/ADAPTER AND NEEDLE/HUB ASSEMBLIES OF A 20GA UNIT WITHOUT THE PROTECTIVE NEEDLE COVER, WHICH REVEALED THE NEEDLE TIP WAS PIERCING THROUGH THE TUBING WALL. THERE WERE TRACES OF THICK MEDIC THROUGHOUT THE UNIT. UNIT: RECEIVED ONE USED 20GA BD INSYTE AUTOGUARD BC IV CATHETER UNIT WITHOUT PACKAGING. THE UNIT WAS IN 2 PORTIONS; PORTION 1 WAS THE CATHETER/ADAPTER ASSEMBLY THAT WAS INTACT AND PORTION 2 WAS THE NEEDLE/HUB ASSEMBLY THAT WAS FULLY RETRACTED WITHIN THE SAFETY SHIELD (BARREL). BOTH PORTIONS HAD TRACES OF DRIED MEDIA. ACCOMPANYING THE RETURNED UNIT WAS A MISCELLANEOUS OPENED PACKAGE CONTAINING A MISCELLANEOUS NEEDLE COVER. BASED ON THE OBSERVATIONS OF THE PROVIDED PHOTO AND THE RETURNED UNIT THE CUT TO THE CATHETER TUBING WAS A RESULT OF THE NEEDLE TIP PIERCING THROUGH THE TUBING WALL. (INDICATIVE OF TIP SPEAR THRU). THE PRESENCE OF THICK MEDIA WITHIN THE CATHETER TIP AREA INDICATES THAT THE NEEDLE AND CATHETER WERE INTACT AT TIME OF ACCESS/INSERTION. CONCLUSION: PHOTO: ALTHOUGH CONFIRMATION OF NEEDLE THROUGH CATHETER WAS IDENTIFIED AND CONFIRMED BASED ON THE OBSERVATION OF THE PHOTO PROVIDED FOR THIS INCIDENT, A ROOT CAUSE COULD NOT BE ESTABLISHED. UNIT: NOT DETERMINED - CONFIRMATION OF THE DEFECT OF NEEDLE THROUGH CATHETER WAS IDENTIFIED AND CONFIRMED AND RESULTED IN A CUT TO THE TUBING WALL (TIP SPEAR THRU). WHERE AND HOW THIS OCCURRED IS INDETERMINATE, AS THE UNIT SHOWN THE PRESENCE OF DRIED MEDIA AT THE TIP OF THE CATHETER TUBING INDICATED THAT THE UNIT WAS INTACT AT TIME OF ACCESS. THERE WAS NO VISIBLE PHYSICAL EVIDENCE TO CONFIRM AND SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE WOULD NOT RETRACT AND THE NEEDLE WAS THROUGH THE CATHETER WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: UNABLE TO REMOVE NEEDLE FROM CATHETER WHEN APPLIED. NEEDLE PIERCED CATHETER INTO CATHETER. (1 OF 2 COMPLAINTS) WE HAVE BEEN NOTIFIED OF A PROBLEM WITH ONE OF YOUR PRODUCTS: INSYTE AUTOGUARD CATHETER BC REF: 381034; LOT: 9112613 OR 9115800 (?) : NON-PRESERVED PACKAGING, LOTS OF DEVICES CURRENTLY IN STOCK IN THE SERVICE. PROBLEM: CAN NOT REMOVE THE NEEDLE FROM THE CATHETER DURING INSTALLATION. NEEDLE PIERCED THE CATHETER IN CATHETER.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE POTENTIAL LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9112613. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2019-04-22. MEDICAL DEVICE LOT #: 9115800. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2019-05-02." 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 THE NEEDLE WOULD NOT RETRACT AND THE NEEDLE WAS THROUGH THE CATHETER WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: UNABLE TO REMOVE NEEDLE FROM CATHETER WHEN APPLIED. NEEDLE PIERCED CATHETER INTO CATHETER. ADDITIONAL INFORMATION: (1 OF 2 COMPLAINTS) WE HAVE BEEN NOTIFIED OF A PROBLEM WITH ONE OF YOUR PRODUCTS: INSYTE AUTOGUARD CATHETER BC REF: 381034; LOT: 9112613 OR 9115800 (?) => NON-PRESERVED PACKAGING, LOTS OF DEVICES CURRENTLY IN STOCK IN THE SERVICE. PROBLEM: CAN NOT REMOVE THE NEEDLE FROM THE CATHETER DURING INSTALLATION. NEEDLE PIERCED THE CATHETER IN CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088932 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other