MAUDE Adverse Event Report: BRACCO INJENEERING SA FASTLOAD CTA; INJECTOR SYSTEM

Model Number 6730

Device Problems Break (1069); Collapse (1099); Detachment of Device or Device Component (2907); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2015

Event Type  malfunction  

Event Description

Product defect in manufacturing of the fastload cta dual syringe pack used in the empower cta and empower cta injector systems.Two of three packages had the locking lugs on the syringe broken off.One of three had the low pressure connecting y-tube blue cap crushed and torn off.These all occurred in the same lot number.None were used on any patients, however, the broken locking lugs on the syringes made them unusable.None of the other dual packs in stock with this lot number had the same defect.Attempts were made to duplicate the error by dropping the packages from 5 feet to the floor.There was no damage.Fastload cta dual syringe pack with spikes contains: 2x 200ml fastload syringes, 1 low pressure connecting t tube, 1 small spike and 1 large spike.

• Brand Name: FASTLOAD CTA
• Type of Device: INJECTOR SYSTEM
• Manufacturer (Section D): BRACCO INJENEERING SA; lusanne, ch ; SZ
• MDR Report Key: 4949666
• MDR Text Key: 6633926
• Report Number: MW5044858
• Device Sequence Number: 2
• Product Code: IZQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2015
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 6730
• Device Catalogue Number: 017347
• Device Lot Number: IADA4-1505
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1