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

Model Number	G08133
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Occupation = non-healthcare professional- distributor.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
As reported, during inspection within a distribution facility, foreign matter described as a piece of black hair was found inside the performer mullins guiding sheath packaging.The device did not make contact with any patient.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during inspection within a distribution facility, foreign matter described as a piece of black hair was found inside the performer mullins guiding sheath packaging.The device did not make contact with any patient.Investigation evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, and quality control was conducted during the investigation.A review of photos, provided by the customer, was also conducted.The complaint device was not returned for investigation; therefore, a physical inspection of the device was not possible.Photos provided by the customer show an unidentified hair-like fiber loose inside of the sealed product package.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints have been received from the field, it was concluded that there is no evidence that other nonconforming product exists in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The product ifu states: "do not use the product if there is doubt as to whether the product is sterile." based on the information provided and the results of the investigation, cook has concluded that a manufacturing deficiency contributed to this incident.The risk analysis for this failure mode was reviewed and no action was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 MULLINS GUIDING SHEATH
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9595735
• Report Number: 1820334-2020-00132
• Device Sequence Number: 19464308
• Product Code: DYB
• UDI-Device Identifier: 00827002081338
• UDI-Public: (01)00827002081338(17)220410(10)9657788
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 06/16/2020

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: 04/10/2022
• Device Model Number: G08133
• Device Catalogue Number: RCFW-8.0-38-63-RB-MTS
• Device Lot Number: 9657788
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 06/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1