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

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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
As reported, prior to patient contact for an unspecified procedure, a hair was found inside the packaging of a micropuncture transitionless access set.There were no reported adverse effects to the patient.
Additional Manufacturer Narrative
Summary of event: as reported, prior to patient contact for an unspecified procedure, a hair was found inside the packaging of a micropuncture transitionless access set.There were no reported adverse effects to the patient.Investigation evaluation: reviews of the complaint history, device history record, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.Cook completed a review of the device history record (dhr).The dhr for the reported lot found one relevant non-conformance on one device, however, the device was re-worked and re-inspected.A database search for complaints reported on the complaint lot reveals no additional complaints at this time.Therefore, cook determined that no nonconforming product exists in house or in the field.The instructions for use does not provide any relevant information related to this failure mode.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided suggests that the device was manufactured out of specification.Based on the available information and results of the investigation, cook has concluded that a manufacturing deficiency/quality control deficiency was the cause of this incident.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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.
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 ACCESS SET
• Common Device Name: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 16622277
• Report Number: 1820334-2023-00326
• Device Sequence Number: 17973123
• Product Code: DYB
• UDI-Device Identifier: 00827002438705
• UDI-Public: (01)00827002438705(17)241119(10)14368347
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K171275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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
• Device Expiration Date: 11/19/2024
• Device Model Number: N/A
• Device Catalogue Number: MPIS-501-NT-SST
• Device Lot Number: 14368347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown