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

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)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional common name: fge catheter, biliary, diagnostic.(b)(4).Customer (person): postal code: (b)(6).Pma/510(k) #: k183036.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
It was reported, that prior to opening the sealed package on a dilator, the user noticed a hair like substance in the package.The device was not used and no patient contact was made.The procedure was completed with another like device.No other adverse effects were reported for this incident.
Additional Manufacturer Narrative
Investigation ¿ evaluation: (b)(6) hospital (japan) contacted cook on 19jul2022 concerning a dilator (rpn: jcd14.0-38-20; lot#: 14623631).When the customer was about to open the device packaging, a hair-like foreign matter was found near the hanging hole end of the packaging.Another device was used to complete the procedure.This was noted prior to use.The patient did not experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.The product was returned to cook for evaluation.One sealed and unused device was received.A hair-like fiber was noted inside the sealed pouch above the label.The failure was confirmed for this complaint.Cook found the product out of specification.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that there are procedures in place to check for this non-conformance prior to distribution.Cook also reviewed the device history record (dhr).The dhr for lot 14623631 recorded no non-conformances nor additional complaints.There is no evidence of non-conforming material in house or in the field.Cook also reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet, t_jcd_rev0.In the how supplied section it states: "upon removal from package, inspect the product to ensure no damage has occurred." 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 a quality control deficiency.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 information regarding the patient and/or event 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: 15114266
• Report Number: 1820334-2022-01286
• Device Sequence Number: 5849953
• Product Code: DRE
• UDI-Device Identifier: 00827002009967
• UDI-Public: (01)00827002009967(17)250325(10)14623631
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2025
• Device Model Number: N/A
• Device Catalogue Number: JCD14.0-38-20
• Device Lot Number: 14623631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2022
• 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