MAUDE Adverse Event Report: COOK INC DILATOR; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	G01328
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: preamendment.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
It was reported that a hair was noted within the sterile packaging of a dilator.As the device was left unopened, no patient contact was made.No adverse effects to the patient were reported.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: b3.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
No additional details regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Correction: g4--pma/510(k): k183036.Investigation ¿ evaluation.(b)(6) hosp & clinic (united states) contacted cook 03aug2021 stating that they found a hair like fiber in a jcd18.0-38-20 package from lot# 13944724.The package was not opened and set aside to be returned to cook.A review of the complaint history, device history record, and quality control, as well as a visual inspection of the returned product, were conducted during the investigation.One prior to use device was returned to cook for evaluation.There was a hair like fiber that can be seen next to the distal tip of the dilator in the sealed package.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for lot# 13944724 found no nonconformances that could have contributed to the reported failure mode.There are no additional complaints for this lot.Cook also reviewed product labeling.This product is not supplied with an instructions for use (ifu) pamphlet.Based on the device failure analysis, device history record, and device master record, there is evidence found that the product was processed through quality control and manufacturing out of specification.There is no evidence of non-conforming material in house or in the field.Based on the information provided, inspection of the returned device, and the results of the investigation, it was determined the cause of this event is related to manufacturing and quality control failure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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 details regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: DILATOR
• Common Device Name: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 12319059
• Report Number: 1820334-2021-01983
• Device Sequence Number: 4173007
• Product Code: DRE
• UDI-Device Identifier: 00827002013285
• UDI-Public: (01)00827002013285(17)240506(10)13944724
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2022

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: Health Professional
• Device Expiration Date: 05/06/2024
• Device Model Number: G01328
• Device Catalogue Number: JCD18.0-38-20
• Device Lot Number: 13944724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 09/17/2021; 06/28/2022
• Initial Report FDA Received Date: 08/13/2021
• Supplement Report FDA Received Date: 09/20/2021; 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown