MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. STELLANT DUAL CT INJECTOR; CT INJECTION SYSTEM

Model Number	60726807
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer declined an injector system checkout.The disposables used in the reported occurrence were discarded and not available for evaluation.In addition, lot numbers were not provided; therefore retained samples are not able to be tested.The customer declined additional applications training.
Event or Problem Description
The customer reported the following: a patient suffered an extravasation while connected to the stellant w/certegra injector system during a ct abdomen/pelvis examination with contrast to evaluate right upper quadrant pain.Post procedure, a small amount of swelling was evident in the left antecubital area.The patient was admitted to the hospital due to an unrelated infection and per site protocol received a skin evaluation performed by wound care.No additional treatment regarding the extravasation was reported.

• Brand Name: STELLANT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 7117494
• Report Number: 2520313-2017-00079
• Device Sequence Number: 16468296
• Product Code: DXT
• UDI-Device Identifier: 00616258008943
• UDI-Public: (01)00616258008943(11)090501
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K082905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 60726807
• Device Catalogue Number: STELLANT W/CERTEGRA
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention