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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This mdr is being submitted past the 30 day reporting requirement as part of a retrospective review of the report.A retrospective review of the complaint record determined that this report should have been submitted as a malfunction report.In this case, no patient injury occurred; however, this may be likely to cause or contribute to a serious injury if it recurred.The preliminary investigation results have been sent today.We will update later if any further information is determined.Investigation - evaluation a review of the complaint history, drawings, functional test, device history record, documentation, instructions for use (ifu), manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation.The device was visually examined.Functional testing could not be completed due to excessive biomaterial that settled in/ around the cap and disc.Destructive testing found an excessive amount of adhesive had been applied to the cap and the side arm fitting.The excess adhesive seeped up under the silicone disc.The proper application of adhesive would be at the transition of the cap to the side arm fitting; not on the threads.The excessive adhesive or the seepage of adhesive up inside the cap would not allow for proper seating of the silicone disc, nor would it allow for proper curing during the uv lighting procedure.It is likely that one of two manufacturing activities contributed to this event: a: too much adhesive was applied, or b: the part was allowed to dwell too long before curing allowing for the adhesive to infuse down through the threads onto the valve.Based on the information provided, no product returned and the results of our investigation, the event is related to a manufacturing issue.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.
Event or Problem Description
Customer reported that a patient was scheduled for an unspecified procedure.Customer states that the product leaks at the check flo valve when flushed prior to the procedure.There was no reported device contact with the patient, and accordingly there are no reported adverse patient consequences.
Additional Manufacturer Narrative
A review of the complaint history, drawings, device history record, documentation, manufacturing instructions, trends, quality control, and visual inspection / functional testing of the returned device was conducted during the investigation.The performer introducer was received in a used condition as evidenced by bio matter in and around the check flo valve/silicone disk.Although attempts were made to functionally test the check flo bodies, we were unsuccessful at recreating the failure due to the dried biomatter which had settled in/around the cap and disc.Destructive testing found an excessive amount of adhesive had been applied to the cap and the side arm fitting, which had seeped up under the silicone disc.Two targeted root causes were identified related to leaking around the silicone disk and through the cap: inadequate tightening of the cap onto the valve body.An interaction between the inadequate tightening of the valve body and excessive glue, resulting in glue between the flange of the valve body and the silicone disk.Excess glue in itself is not a root cause, but rather a contributing factor in concert with under tightening of the cap.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6530437
• Report Number: 1820334-2017-00943
• Device Sequence Number: 1202156
• Product Code: DYB
• UDI-Device Identifier: 00827002106758
• UDI-Public: (01)00827002106758(17)180616(10)5964945
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2017

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 Model Number: N/A
• Device Catalogue Number: RYCFW-6.0-35-6-RB-CW
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/09/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 06/02/2017
• Patient Sequence Number: 1