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

Model Number	G28322
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number: pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, a foreign matter like eyelash was confirmed inside the unopened package by the distributor.
Event or Problem Description
No additional information has been added to the description of event since the previous medwatch report was submitted.
Additional Manufacturer Narrative
D10: product received on 27dec2018.Investigation evaluation : a review of the complaint history, instructions for use (ifu), inspection of unused device, visual inspection, device history record and quality control and specifications of the device was conducted during the investigation.One unopened device was returned to aid in the investigation.Examination of the returned product identified foreign matter was noted in the outer packaging.During the investigation, a review of quality control instructions and product labeling was conducted.Based on the review of current documentation, sufficient controls and inspections are in place to prevent the release of nonconforming product related to the reported failure mode.Additionally, a review of the complaint device lot and similar device lots was conducted and found no relevant nonconformances during pre-release testing.A review of complaints was conducted and identified one other potential relevant complaint from the device lot.There is no evidence that nonconforming product exists in house or in the field.As a result of our investigation, examination of the returned product, and the available information the root cause was traced to manufacturing.Per the quality engineering risk assessment, no further action is required.The appropriate personnel were notified, and cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: PERFORMER INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8180523
• Report Number: 1820334-2018-03508
• Device Sequence Number: 11063532
• Product Code: DYB
• UDI-Device Identifier: 00827002283220
• UDI-Public: (01)00827002283220(17)211012(10)9173691
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

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: No Information
• Device Expiration Date: 10/12/2021
• Device Model Number: G28322
• Device Catalogue Number: RCF-16.0-38-J
• Device Lot Number: 9173691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1