MAUDE Adverse Event Report: COOK INC MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).**investigation** the event was determined to be reportable during the investigation based on a quality engineer risk assessment that was conducted on 12 september 2016.The addition of this complaint does not change the overall risk.No further risk reduction is necessary at this time.A review of device history record, instructions for use (ifu), quality control (qc) and a visual inspection was conducted during the investigation.Instructions are in place to verify that the device is manufactured to specifications.In spite of the images being provided, there is no confirmation of the alleged deficiency via photographs.The device was returned in a condition that prevents functional or dimensional testing.Therefore, we cannot determine with certainty what led to this failure mode.For this reason, a conclusive root cause cannot be determined.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.
Event or Problem Description
The catheter was placed in the patient with no complications and was working fine.The patient was transported to the room and it was noted that the device started leaking at the hub.Upon inspection a crack was detected in the seal of the hub.The patient was brought back to surgery and the device exchanged.No harm to the patient.

• Brand Name: MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
• Common Device Name: DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5960667
• Report Number: 1820334-2016-00979
• Device Sequence Number: 18856484
• Product Code: DQO
• UDI-Device Identifier: 00827002064201
• UDI-Public: (01)00827002064201(17)160901(10)4407008
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2016

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: N/A
• Device Catalogue Number: MCIS-5.0-35-65-15.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2016
• Initial Report FDA Received Date: 09/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1