BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST LOAD CT SYRINGE PACK

    MDR report key: 6983183 · Received October 27, 2017

    Report

    Report Number
    3004753774-2017-00007
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    September 27, 2017
    Report Date
    September 28, 2017
    Manufacturer
    BRACCO INJENEERING S.A.
    Product Code
    DXT
    UDI-DI
    17630039300309
    PMA / PMN Number
    K933846
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON TWO DECADES OF EXPERIENCE WITH THE EMPOWER INJECTOR, IT IS THE OPINION OF BRACCO MEDICAL ADVISORY BOARD MEMBER THAT THE LIKELIHOOD OF A SYRINGE BURST IS VERY SMALL AND IF ONE SHOULD OCCUR, THE LIKELIHOOD OF SERIOUS HARM OR PERMANENT INJURY OR DISABILITY TO PATIENTS OR HEALTHCARE PERSONNEL IS EXTREMELY LOW WHEN COMPARED TO THE TOTAL OF DEVICES SOLD ON THE MARKET (2 PPM).

    Description of Event or Problem · 0

    ON 28-SEP-2017 A HEALTHCARE PROFESSIONAL REPORTED TO BRACCO INJENEERING A DEVICE MALFUNCTION WITH THE USE OF FASTLOAD CT SYRINGE PACK. THE REPORT WAS FORWARDED TO BRACCO DRUG SAFETY ON 20-OCT-2017. ON (B)(6) 2017 AT A BEGINNING OF A CT INJECTION, THE SYRINGE BROKE. NO PATIENT OR USER/OPERATOR INJURY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: 06-NOV-2017: FOLLOW UP: 3500A MEDWATCH COMPLETED BY MANUFACTURER OF FASTLOAD CT SYRINGE PACK ATTACHED TO THE CASE. NO NEW INFORMATION WAS RECEIVED FOR THIS REPORT. 02-JUL-2018: BINJ RECEIVED FOLLOW-UP INFORMATION WHICH WAS SENT TO BRACCO ON 27-JUL-2018. DETAILED DESCRIPTION OF THE DEVICE MALFUNCTION WAS ADDED TO THE CASE. THIS CASE IS MEDICALLY CLOSED. UDI NUMBER: (B)(4). BRACCO WORLDWIDE CASE ID#: (B)(4). COMPANY COMMENT: BASED ON TWO DECADES OF EXPERIENCE WITH THE EMPOWER INJECTOR, IT IS THE OPINION OF BRACCO MEDICAL ADVISORY BOARD MEMBER THAT THE LIKELIHOOD OF A SYRINGE BURST IS VERY SMALL AND IF ONE SHOULD OCCUR, THE LIKELIHOOD OF SERIOUS HARM OR PERMANENT INJURY OR DISABILITY TO PATIENTS OR HEALTHCARE PERSONNEL IS EXTREMELY LOW WHEN COMPARED TO THE TOTAL OF DEVICES SOLD ON THE MARKET (2 PPM).

    Additional Manufacturer Narrative · 1

    AT A BEGINNING OF A CT INJECTION, THE SYRINGE BROKE. NO PATIENT OR USER/OPERATOR INJURY. NO SAMPLE HAS BEEN RECEIVED AND INVESTIGATION IS ONGOING. IT HAS BEEN DECIDED TO REPORT THIS PRODUCT PROBLEM IN CASE THIS IS RELATED TO SYRINGE THAT POPPED OUT DURING INJECTION (WITH A POTENTIAL OF INJURY, IF THE ISSUE WAS TO REOCCUR). INVESTIGATION IS ONGOING. COMPANY COMMENTS: THIS IS A REPORT OF MALFUNCTION WITH THE USE OF FASTLOAD CT SYRINGE PACK WHICH OCCURRED AT A BEGINNING OF THE CT SCAN. THE SPECIFIC MALFUNCTION WAS NOT DESCRIBED, HOWEVER NO PATIENT/USER INJURY WAS REPORTED. THIS INCIDENCE IS BEING REPORTED BY THE COMPANY SINCE THERE MAY BE THE POTENTIAL OF INJURY IF THE ISSUE WAS TO REOCCUR. A QUALITY INVESTIGATION IS ONGOING. (B)(4).

    Additional Manufacturer Narrative · 1

    AT A BEGINNING OF A CT INJECTION, THE SYRINGE BROKE. NO PATIENT OR USER/OPERATOR INJURY. NO SAMPLE HAS BEEN RECEIVED AND INVESTIGATION IS ONGOING. IT HAS BEEN DECIDED TO REPORT THIS PRODUCT PROBLEM IN CASE THIS IS RELATED TO SYRINGE THAT POPPED OUT DURING INJECTION (WITH A POTENTIAL OF INJURY, IF THE ISSUE WAS TO REOCCUR). INVESTIGATION IS ONGOING. COMPANY COMMENTS: THIS IS A REPORT OF MALFUNCTION WITH THE USE OF FASTLOAD CT SYRINGE PACK WHICH OCCURRED AT A BEGINNING OF THE CT SCAN. THE SPECIFIC MALFUNCTION WAS NOT DESCRIBED, HOWEVER NO PATIENT/USER INJURY WAS REPORTED. THIS INCIDENCE IS BEING REPORTED BY THE COMPANY SINCE THERE MAY BE THE POTENTIAL OF INJURY IF THE ISSUE WAS TO REOCCUR. A QUALITY INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    ON (B)(6) 2017 A HEALTHCARE PROFESSIONAL REPORTED TO BRACCO INJENEERING A DEVICE MALFUNCTION WITH THE USE OF FASTLOAD CT SYRINGE PACK. THE REPORT WAS FORWARDED TO BRACCO DRUG SAFETY ON 20-OCT-2017. ON (B)(6) 2017 AT A BEGINNING OF A CT INJECTION (SCAN), THE FASTLOAD CT SYRINGE BROKE. NO PATIENT/USER INJURY WAS REPORTED. HOWEVER THERE MAY BE THE POTENTIAL OF INJURY IF THE ISSUE WAS TO REOCCUR. A QUALITY INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION IS REQUIRED. 06-NOV-2017: FOLLOW UP: 3500A MEDWATCH COMPLETED BY MANUFACTURER OF FASTLOAD CT SYRINGE PACK ATTACHED TO THE CASE. NO NEW INFORMATION WAS RECEIVED FOR THIS REPORT. UDI NUMBER: (B)(4). BRACCO WORLDWIDE CASE ID#: (B)(4).

    Description of Event or Problem · 1

    ON 28-SEP-2017 A HEALTHCARE PROFESSIONAL REPORTED TO BRACCO INJENEERING A DEVICE MALFUNCTION WITH THE USE OF FASTLOAD CT SYRINGE PACK. THE REPORT WAS FORWARDED TO BRACCO DRUG SAFETY ON 20-OCT-2017. ON (B)(6) 2017 AT A BEGINNING OF A CT INJECTION (SCAN), THE FASTLOAD CT SYRINGE BROKE. NO PATIENT/USER INJURY WAS REPORTED. HOWEVER THERE MAY BE THE POTENTIAL OF INJURY IF THE ISSUE WAS TO REOCCUR. A QUALITY INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION IS REQUIRED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762384 FAST LOAD CT SYRINGE PACK FAST LOAD CT SYRINGE PACK DXT BRACCO INJENEERING S.A. 017344 IALBR-1706 17630039300309

    Patients

    Seq Age Sex Outcome Treatment
    1