FastLoad™ CT Syringe Pack 017344Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 17630039300309), received between Feb 13, 2017 and Oct 27, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 12, 2018Class IITerminated

   Insufficient seal on the sterile barrier of the device, compromising the sterility of the device

   Z-0654-2019 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2017Material Integrity Problem; Material Integrity Problem

  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).

  Patient problems: No Patient Involvement

  MAUDE report 6983183 ↗
• MalfunctionApr 14, 2017Material Integrity Problem; Material Integrity Problem

  ON 23-FEB-2017, A TECHNOLOGIST REPORTED TO BRACCO INJENEERING (BINJ) A DEVICE MALFUNCTION WITH THE USE OF FASTLOAD CTA SYRINGE. THE REPORT WAS FORWARDED TO BRACCO DRUG SAFETY ON 13-APR-2017. ON (B)(6) 2017, DURING A CT INJECTION, THE SYRINGE POPPED OUT OF THE CT INJECTOR AND LANDED ON A PILLOW NEXT TO THE PATIENT. NO PATIENT OR PERSON HAS BEEN REPORTED INJURED IN THIS EVENT. THERE WAS ONLY A POTENTIAL FOR INJURY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: 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. BRACCO WORLDWIDE CASE ID#: (B)(4). (PREVIOUSLY REPORTED AS (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).

  Patient problems: No Patient Involvement

  MAUDE report 6494503 ↗
• MalfunctionFeb 15, 2017Material Integrity Problem; Material Integrity Problem

  ON 16-JAN-2017, A TECHNOLOGIST REPORTED TO BRACCO INJENEERING (BINJ) A DEVICE MALFUNCTION WITH THE USE OF FASTLOAD CTA SYRINGE. THE REPORT WAS FORWARDED TO BRACCO DRUG SAFETY ON 10-FEB-2017. ON 16-JAN-2017, AFTER 10 ML OF A 50 ML ISOVUE CONTRAST MEDIA INJECTION, THE CM SYRINGE POPPED OUT OF THE INJECTOR AND LANDED ON THE TABLE. NO PATIENT OR PERSON HAS BEEN REPORTED INJURED IN THIS EVENT. THERE WAS ONLY A POTENTIAL FOR INJURY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: 02-JUL-2018: BINJ RECEIVED FOLLOW-UP INFORMATION WHICH WAS SENT TO BRACCO ON 27-JUL-2018. DETAILED DESCRIPTION OF THE DEVICE MALFUNCTION, RELEVANT TEST (CAPA) WAS ADDED TO THE CASE. THIS CASE IS MEDICALLY CLOSED. BRACCO WORLDWIDE CASE ID#: (B)(4) (PREVIOUSLY REPORTED AS (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).

  Patient problems: No Patient Involvement

  MAUDE report 6332861 ↗
• MalfunctionFeb 13, 2017Material Integrity Problem; Material Integrity Problem

  ON (B)(6) 2017, A TECHNOLOGIST REPORTED TO BRACCO INJENEERING (BINJ) A DEVICE MALFUNCTION WITH THE USE OF THE FASTLOAD CT SYRINGE. THE REPORT WAS FORWARDED TO BRACCO DRUG SAFETY ON 09-FEB-2017. ON (B)(6) 2017, DURING AN INJECTION IN THE MORNING, THE TECH WAS DOING A ISOVUE 370 50ML INJECTION AND THE CM SYRINGE POPPED OUT OF THE INJECTOR AND LANDED ON TOP OF THE PATIENT (BEFORE INJECTION OF CONTRAST AND SCAN). PRESSURE WAS NORMAL. NO PATIENT OR PERSON HAS BEEN REPORTED INJURED IN THIS EVENT. THERE WAS ONLY A POTENTIAL FOR INJURY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: 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. FDA#: 3004753774-2017-00001 BRACCO WORLDWIDE CASE ID#: (B)(4). (PREVIOUSLY REPORTED AS (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

  Patient problems: No Patient Involvement

  MAUDE report 6325463 ↗