MAUDE Adverse Event Report: COOK INC PERFORMER INTRODUCER; DYB INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event is still under investigation at this time.
Event or Problem Description
During an unknown procedure on the male patient it was noted that there was blood leakage from the fitting of the check-flo valve.The device was replaced with another manufacturer's device and the procedure was completed successfully.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
(b)(4).(additional information provided/updated): investigation/evaluation: during the course of the investigation, a review of the complaint history, manufacturing instructions, quality control, device history record, and trends of the product was conducted.Neither the actual used product nor photographs were returned for investigation.Based on the information provided we were unable to determine the root cause of this event.However, it is feasible from the review of the consumers description of the event, that the valve was dislodged when the dilator was inserted into the sheath.We will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
During an unknown procedure on the male patient it was noted that there was blood leakage from the fitting of the check-flo valve.The device was replaced with another manufacturer's device and the procedure was completed successfully.There have been no adverse effects to the patient reported.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5649716
• Report Number: 1820334-2016-00300
• Device Sequence Number: 16195095
• Product Code: DYB
• UDI-Device Identifier: 00827002095823
• UDI-Public: (01)00827002095823(17)181103(10)6169175
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2016

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 Model Number: N/A
• Device Catalogue Number: RCFW-16.0P-38-70-RB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/21/2016
• Device Age: 6 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2016
• Supplement Report FDA Received Date: 07/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1