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)
Date of Event	06/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a performer introducer was used for inserting a dialysis introducer.It was discovered that the device is leaking from the hub.There were no adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
Investigation-evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and functional testing of the returned device was conducted during the investigation.One used sheath and the dilator of the performer introducer were returned for investigation.Leakage was present from the valve when the dilator was removed from the sheath.No leakage is noted with the dilator fully inserted.The device was also tested for presence of excessive glue but none was found.The distance between the top of the cap to the bottom of the cap was measured and was found to be measuring 1.3885 inches.If the cap top to cap bottom measures more than 1.370", this usually indicates under-tightening of the cap to the valve body.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation; the root cause of the leakage has been identified as inadequate tightening of the cap onto the valve body.Measures have been conducted to address this failure mode.Appropriate personnel have been notified and 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: 6734294
• Report Number: 1820334-2017-01644
• Device Sequence Number: 13726937
• Product Code: DYB
• UDI-Device Identifier: 00827002106758
• UDI-Public: (01)00827002106758(17)200414(10)7832778
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2017

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
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 10/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1