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

Model Number	G28445
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-healthcare professional.Pma/510(k) number = pre-amendment.This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.
Event or Problem Description
It was reported, the bottom of the package containing a performer introducer was not sealed.There did not appear to have a line delineating a sterile sealed barrier.The inside package was still sterile and the customer was able to use the device as the inner packaging was sealed.Another package with the same product and lot number was checked and no issue was found.There was no patient adverse effect as a result of this occurrence.Product will not be returned to the manufacturer to aid in the investigation since the inner packaging remained sterile and was used in the procedure.
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, instructions for use (ifu), manufacturer¿s instructions, quality control, 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.This photo did reveal the failure, there was no evidence that the package was sealed at the bottom.Additionally, document based investigation evaluation was performed.There is evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which states ¿how supplied-supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile." based on the information provided and no product returned, investigation has concluded that this event can be traced to manufacturing and quality control.Accordingly, the individuals responsible for the effected lot were retrained in both manufacturing and quality control, respectfully.Measures are being conducted to address this failure mode.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 INTRODUCER
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8633946
• Report Number: 1820334-2019-01252
• Device Sequence Number: 1857751
• Product Code: DYB
• UDI-Device Identifier: 00827002284456
• UDI-Public: (01)00827002284456(17)220410(10)9614940
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: 04/10/2022
• Device Model Number: G28445
• Device Catalogue Number: RCFW-16.0P-38-45-RB
• Device Lot Number: 9614940
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1