MAUDE Adverse Event Report: COOK INC MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET; DYB INTRODUCER, CATHETER

Model Number	G35550
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) number = k133114.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, a customer received two micropuncture transitionless stiffened cannula access sets from this lot that were frayed.The product did not make patient contact and no other procedures were necessary.There was no patient adverse effect.
Additional Manufacturer Narrative
Investigation/evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no 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, drawing, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided and no product returned, investigation has concluded that the transportation and storage of the device are the likely causes of this event.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8613670
• Report Number: 1820334-2019-01133
• Device Sequence Number: 1685506
• Product Code: DYB
• UDI-Device Identifier: 00827002355507
• UDI-Public: (01)00827002355507(17)220320(10)9607556
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 07/15/2019

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: 03/20/2022
• Device Model Number: G35550
• Device Catalogue Number: MPIS-402-10.0-SC-NT-U-SST
• Device Lot Number: 9607556
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1