MAUDE Adverse Event Report: BRACCO INJENEERING S.A. FASTLOAD CTA SYRINGE PACK

Model Number	017344
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/16/2017
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 not been sent by the end-user.A demand has been done to retrieve the sample for investigation purpose.The manufacturing records demonstrates that the product lot has been correctly manufactured in accordance to the specifications.Records show no evidence of defects from manufacturing.Investigation is ongoing.(b)(4).
Event or Problem Description
On 17-jan-2017, a technologist reported to bracco injeneering (binj) a device malfunction with the use of fast load cta syringe.The report was forwarded to bracco drug safety on 10-feb-2017.On (b)(6) 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.A quality investigation is ongoing.Additional information is required.
Event or Problem Description
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).
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).The case is considered as closed.

• Brand Name: FASTLOAD CTA SYRINGE PACK
• Common Device Name: FASTLOAD CTA SYRINGE PACK
• Manufacturer (Section D): BRACCO INJENEERING S.A.; avenue de sevelin 46; lausanne, vaud CH 10 04; SZ CH 1004
• MDR Report Key: 6332861
• Report Number: 3004753774-2017-00002
• Device Sequence Number: 1105461
• Product Code: DXT
• UDI-Device Identifier: 17630039300309
• UDI-Public: (01)17630039300309(17)191108(11)161108(10)
• 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: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2017

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: Other Health Care 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: 01/17/2017
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 02/15/2017
• 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