MAUDE Adverse Event Report: BRACCO INJENEERING S.A. FASTLOAD CT SYRINGE PACK; CT INJECTOR SYRINGE

Model Number	017344
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient or person has been reported injured in this event.The staff was not in a position to be injured.There was only a potential for injury to the patient if the issue would re-occur.This event is being investigated.The defective syringe has been received and sent to contract manufacturer to continue the investigation.One(1) lot # was initially reported from the end-user (as described in this form) but another lot # was potentially sent by end-user for investigation (lot number iahpn-1608, manufacture date = 31-08-2016, expiration date = 31.08.2019).Investigation will clarify this discrepancy in end-user information.All manufacturing records show that both product lots have been correctly manufactured in accordance to the specifications.Records show no evidence of defects from manufacturing.Injector log file analysis show no evidence of defects from injector.Investigation is ongoing.
Event or Problem Description
On (b)(6) 2017, a technologist reported to (b)(4) a device malfunction with the use of the fastload ct syringe.The report was forwarded to (b)(4) on 09-feb-2017.On (b)(6) 2017, during an injection in the morning, the technologist was doing an isovue 370 50ml injection and the contrast media (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.A quality investigation is ongoing.Additional information is required.
Event or Problem Description
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 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).

• Brand Name: FASTLOAD CT SYRINGE PACK
• Common Device Name: CT INJECTOR SYRINGE
• Manufacturer (Section D): BRACCO INJENEERING S.A.; avenue de sevelin 46; lausanne, vaud 1004 ; SZ 1004
• MDR Report Key: 6325463
• Report Number: 3004753774-2017-00001
• Device Sequence Number: 13723500
• Product Code: DXT
• UDI-Device Identifier: 17630039300309
• UDI-Public: (01)17630039300309(17)191108(11)161108(10)IAITX-1611
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 01/14/2017

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: 11/08/2019
• Device Model Number: 017344
• Device Catalogue Number: 017344
• Device Lot Number: IAITX-1611
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2017
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 02/13/2017
• Supplement Report FDA Received Date: 08/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1