MAUDE Adverse Event Report: BRACCO INJENEERING S.A. FASTLOAD CT SYRINGE PACK WITH SPIKE

Model Number	017345
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During a ct injection, the syringe popped out of the ct injector.No patient or user/operator injury.However there may be the potential of injury, if the issue was to reoccur.Investigation is ongoing.Company comments: this is a device malfunction with the use of fastload cta dual syringe pack with spikes.During a ct injection, the syringe popped out of the ct injector.No patient or user/operator injury.However there may be the potential of injury, if the issue was to reoccur.A quality investigation of the device is ongoing.
Event or Problem Description
On (b)(6) 2017, a healthcare professional reported to bracco injeneering (binj) a device malfunction with the use of fastload ct syringe pack with spike.The report was forwarded to bracco drug safety on 16-jun-2017.On (b)(6) 2017, during a ct injection, the syringe popped out of the ct injector.No patient or user/operator injury.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).
Event or Problem Description
On 21-mar-2017, a healthcare professional reported to bracco injeneering (binj) a device malfunction with the use of fastload ct syringe pack with spike.The report was forwarded to bracco drug safety on 16-jun-2017.On 15-mar-2017 during a ct injection, the syringe popped out of the ct injector.No patient or user/operator injury.However there may be the potential of injury, if the issue was to reoccur.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#: (b)(4).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).
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).The unique device identifier(udi) number: (b)(4).This case is considered as closed.

• Brand Name: FASTLOAD CT SYRINGE PACK WITH SPIKE
• Common Device Name: FASTLOAD CT SYRINGE PACK WITH SPIKE
• Manufacturer (Section D): BRACCO INJENEERING S.A.; avenue de sevelin 46; lausanne, vaud CH-10 04; SZ CH-1004
• MDR Report Key: 6735274
• Report Number: 3004753774-2017-00005
• Device Sequence Number: 2013589
• Product Code: DXT
• UDI-Device Identifier: 17630039300316
• UDI-Public: (01)17630039300316(17)191118(11)161118(10)IAIWX-1611
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2017

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: 11/18/2019
• Device Model Number: 017345
• Device Catalogue Number: 017345
• Device Lot Number: IAIWX-1611
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2017
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1