BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9717302 · Received February 17, 2020

    Report

    Report Number
    1710034-2020-00085
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 21, 2020
    Report Date
    April 15, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815129
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD RECEIVED ONE UNUSED INSYTE AUTOGUARD 24GA NEEDLE/BARREL ASSEMBLY AND A NEEDLE COVER IN AN OPENED PACKAGE FROM MATERIAL NUMBER 381512, LOT NUMBER 9193539. IN ADDITION, ONE PHOTOGRAPH WAS RECEIVED WHICH DISPLAYED SIMILARITIES TO THAT OF THE RETURNED UNIT. THROUGH THE VISUAL EXAMINATION, THE CATHETER ADAPTER ASSEMBLY WAS NOT RETURNED THEREFORE THE REPORTED ISSUE OF THE CATHETER ADAPTER BEING DEFECTIVE OR DAMAGED COULD NOT BE CONFIRMED. THE REPORTED ISSUE OF THE ADAPTER / CONNECTOR MISSING WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO AN OPERATOR ERROR DURING THE INSPECTION PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381512 BATCH NO.: 9193539. MATERIAL NO.: 381512, BATCH NO.: 9193539. IT WAS REPORTED THE CATHETER WAS DEFECTIVE WHICH CAUSED AN UNSUCCESSFUL IV ATTEMPT. IT WAS ALSO REPORTED THAT THE WINGED PLASTIC CATHETER WAS MISSING FROM AN UNUSED PACKAGE. PER RESPONSE EMAIL: 2. PLEASE PROVIDE A DETAILED EXPLANATION OF THE ISSUE INCLUDING IF IT OCCURRED BEFORE/DURING/AFTER PATIENT USE AND IF ANY HARM/INJURY, MEDICAL ACTION OR CHANGE TO TREATMENT WAS REQUIRED. I WAS AT A PATIENT¿S HOUSE FOR HOME INFUSION OF IVIG. I HAD ATTEMPTED IV ACCESS WITH ANOTHER 24G CATHETER THAT WAS UNSUCCESSFUL. I WENT TO SUPPLIES AND GRABBED ABOVE MENTIONED 24G CATHETER IN THE PACKAGE. I WENT TO WHERE PATIENT WAS SITTING TO PREPARE THE IV FOR INSERTION. I OPENED THE PACKAGE AND TOOK OFF THE PLASTIC CAP TO LOOSEN THE PLASTIC WINGS (AS I ALWAYS DO SO IT IS EASIER TO THREAD INTO VEIN). WHEN I TOOK OFF THE PLASTIC CAP, THERE WAS NO WINGED PLASTIC CATHETER. I IMMEDIATELY SET THE ABOVE MENTIONED CATHETER ASIDE AND GOT ANOTHER 24G CATHETER FROM PATIENT SUPPLIES AND WAS ABLE TO OBTAIN IV ACCESS SUCCESSFULLY. NO HARM TO PATIENT. I LUCKILY HAD MORE CATHETERS IN SUPPLY SO IT DIDN¿T AFFECT PATIENT¿S INFUSION SCHEDULE TO REPLACE SUPPLIES. 3. IF A PATIENT WAS INVOLVED, ARE ANY PATIENT IDENTIFIERS AVAILABLE? (E.G. AGE, WEIGHT, GENDER, INITIALS, ETC.) N/A NO AFFECT TO PATIENT. PER EMAIL: I NEED TO MAKE AN INCIDENT REPORT ABOUT A 24G CATHETER THAT WAS DEFECTIVE THAT HAPPENED ON (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    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 WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 381512, BATCH NO.: 9193539. IT WAS REPORTED THE CATHETER WAS DEFECTIVE WHICH CAUSED AN UNSUCCESSFUL IV ATTEMPT. IT WAS ALSO REPORTED THAT THE WINGED PLASTIC CATHETER WAS MISSING FROM AN UNUSED PACKAGE. PER RESPONSE EMAIL: PLEASE PROVIDE A DETAILED EXPLANATION OF THE ISSUE INCLUDING IF IT OCCURRED BEFORE/DURING/AFTER PATIENT USE AND IF ANY HARM/INJURY, MEDICAL ACTION OR CHANGE TO TREATMENT WAS REQUIRED. I WAS AT A PATIENT¿S HOUSE FOR HOME INFUSION OF IVIG. I HAD ATTEMPTED IV ACCESS WITH ANOTHER 24G CATHETER THAT WAS UNSUCCESSFUL. I WENT TO SUPPLIES AND GRABBED ABOVE MENTIONED 24G CATHETER IN THE PACKAGE. I WENT TO WHERE PATIENT WAS SITTING TO PREPARE THE IV FOR INSERTION. I OPENED THE PACKAGE AND TOOK OFF THE PLASTIC CAP TO LOOSEN THE PLASTIC WINGS (AS I ALWAYS DO SO IT IS EASIER TO THREAD INTO VEIN). WHEN I TOOK OFF THE PLASTIC CAP, THERE WAS NO WINGED PLASTIC CATHETER. I IMMEDIATELY SET THE ABOVE MENTIONED CATHETER ASIDE AND GOT ANOTHER 24G CATHETER FROM PATIENT SUPPLIES AND WAS ABLE TO OBTAIN IV ACCESS SUCCESSFULLY. NO HARM TO PATIENT. I LUCKILY HAD MORE CATHETERS IN SUPPLY SO IT DIDN¿T AFFECT PATIENT¿S INFUSION SCHEDULE TO REPLACE SUPPLIES. IF A PATIENT WAS INVOLVED, ARE ANY PATIENT IDENTIFIERS AVAILABLE? (E.G. AGE, WEIGHT, GENDER, INITIALS, ETC.) N/A NO AFFECT TO PATIENT. PER EMAIL: I NEED TO MAKE AN INCIDENT REPORT ABOUT A 24G CATHETER THAT WAS DEFECTIVE THAT HAPPENED ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181869 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381512 9193539 30382903815129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other