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

Model Number	017346
Medical Device Problem Codes	Material Integrity Problem (2978); Device Handling Problem (3265)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During a ct injection setup, 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.There was 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 cta dual syringe pack.The report was forwarded to bracco drug safety on (b)(6) 2017.On (b)(6) 2017, during a ct injection set up, 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.
Additional Manufacturer Narrative
During a ct injection setup, 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.On july 26, 2017, the device (incriminated sample) was received in bracco injeneering, but there was no syringe in the package, just the y-line (tubing) with the saline connector broken off.Customer support eventually confirmed on august 31st, 2017 that it was not the syringe that broke but the saline connector of the y-line that was broken off (this is a feature of the y-line).By checking the received sample (y-line) it was possible to conclude that most likely the nurse during the set up of the injector or after injection might have hit the connector or overtightened it.This report is considered as the final investigation report.Company comment: 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.There was no patient or user/operator injury.However there may be the potential of injury, if the issue was to reoccur.Quality investigation confirmed that it was not the syringe that broke but the saline connector of the y-line which could be user related during set-up of the system.
Event or Problem Description
On (b)(6) 2017, a healthcare professional reported to bracco injeneering (binj) a device malfunction with the use of fastload cta dual syringe pack.The report was forwarded to bracco drug safety on 13-jul-2017.On (b)(6) 2017, during a ct injection set up, 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.31-aug-2017: the results of the quality investigation was received by binj.On 31-aug-2017, it was confirmed that it was not the syringe that broke but the saline connector of the y-line that was broken off.By checking the received sample (y-line) it was possible to conclude that most likely the nurse, during the set up of the injector or after injection, might have hit the connector or overtighted it.This report is considered as the final investigation report.This case is medically closed.

• Brand Name: FASTLOAD CTA DUAL SYRINGE PACK
• Common Device Name: CT INJECTOR SYRINGE
• Manufacturer (Section D): BRACCO INJENEERING S.A.; avenue de sevelin 46; lausanne, vaud CH-10 04; SZ CH-1004
• MDR Report Key: 6735277
• Report Number: 3004753774-2017-00006
• Device Sequence Number: 1566122
• Product Code: DXT
• UDI-Device Identifier: 17630039300323
• UDI-Public: (01)17630039300323
• 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
• Report Date (Section B): 08/31/2017

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: 04/05/2020
• Device Model Number: 017346
• Device Catalogue Number: 017346
• Device Lot Number: IAKE5-1704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1