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

Model Number	G09136
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/18/2019
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 at a distribution facility, an unidentified particle was found inside the package of a performer mullins guiding sheath.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, unavailable, or unchanged.Investigation - evaluation: reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control procedures, specifications, and a visual inspection of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a photo of the device was provided.Upon review the photo, a red unidentified particle was loose inside the package.Additionally, a document based investigation evaluation was performed.A review of the device history revealed one non-conformance which could potentially be related to the reported failure.It should be noted, however, that those items were removed and reworked prior to order completion.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, specifications, drawings, and quality control procedures were conducted, and no gaps were discovered.An ifu is also provided with this device, which instructs ¿do not use the product if there is doubt as to whether the product is sterile.¿ goes on to note ¿upon removal from package, inspect product to ensure no damage has occurred.¿ based on the information provided and no product returned, investigation has concluded that this event could be traced to a manufacturing deficiency.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or 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: 9244260
• Report Number: 1820334-2019-02698
• Device Sequence Number: 11276291
• Product Code: DYB
• UDI-Device Identifier: 00827002091368
• UDI-Public: (01)00827002091368(17)220205(10)9500791
• 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): 12/16/2019

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: 02/05/2022
• Device Model Number: G09136
• Device Catalogue Number: RCFW-12.0-38-85-RB-MTS
• Device Lot Number: 9500791
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1