MAUDE Adverse Event Report: BRACCO INJENEERING S.A. FAST LOAD CT SYRINGE PACK

Model Number	017344
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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).
Additional Manufacturer Narrative
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).
Event or Problem Description
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).
Additional Manufacturer Narrative
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).
Event or Problem Description
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).

• Brand Name: FAST LOAD CT SYRINGE PACK
• Common Device Name: FAST LOAD CT SYRINGE PACK
• Manufacturer (Section D): BRACCO INJENEERING S.A.; avenue de sevelin 46; lausanne, vaud CH-10 04; SZ CH-1004
• MDR Report Key: 6983183
• Report Number: 3004753774-2017-00007
• Device Sequence Number: 1197364
• Product Code: DXT
• UDI-Device Identifier: 17630039300309
• UDI-Public: (01)17630039300309
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K933846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2020
• Device Model Number: 017344
• Device Catalogue Number: 017344
• Device Lot Number: IALBR-1706
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 09/28/2017; 09/28/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 11/06/2017; 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1