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

Model Number	N/A
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.
Event or Problem Description
It is alleged that a package containing the performer introducer product was being inspected when a "fluff," or foreign matter, was found in the package.No adverse events have been reported regarding this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, quality control, and visual inspection of the returned device was conducted during the investigation.One new performer introducer was returned for investigation due to foreign material.A 1 mm long blue particle and a 6 mm dark fiber were visible within the sealed outer package.Review of the device history record of the shows one nonconforming event; however all non-conforming product was re-worked prior to completion of the final lot.There were no other reported complaints for this lot number.Per packaging qc specification, a 100% inspection is performed to inspect all package seals prior to release.Based on the information provided, examination of the returned product, and the results of our investigation; the root cause has been determined to be manufacturing related.Per the quality engineering risk assessment, no further action is required.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: 6764952
• Report Number: 1820334-2017-02100
• Device Sequence Number: 13825705
• Product Code: DYB
• UDI-Device Identifier: 00827002074934
• UDI-Public: (01)00827002074934(17)200410(10)NS7775294
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RCF-11.0-38-J
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement 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