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

Model Number	N/A
Medical Device Problem Codes	Unsealed Device Packaging (1444); Device Damaged Prior to Receipt by User (1570)
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.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 to cook that a coons dilator arrived to the customer in an unsealed package.The device was unused and made no patient contact.No adverse effects were reported for this incident.
Event or Problem Description
In additional information received on 27jul2022, the customer reported that, "we think it must have gotten hot in the truck, the seal was open on it.The item itself looked fine, we just couldn't use it on a patient because it arrived unsealed." the complaint device was received by the manufacturer on 01aug2022.It was noted during the preliminary investigation that although the chevron area was open, there were traces of adhesive found on the clear film.
Additional Manufacturer Narrative
Correction: h6 (annex a).Correction: during the preliminary investigation, the device failure analysis found that adhesive was present on the packaging and the seal was, in fact not, entirely missing.Damage to packaging was noticeable by the end user.The event is now not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury and/or product malfunction.Updated reports regarding this event will no longer be provided.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.
Additional Manufacturer Narrative
D2a - additional common name: fge catheter, biliary, diagnostic.D2b- additional product code: fge.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 information regarding patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: COONS 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: 15125566
• Report Number: 1820334-2022-01294
• Device Sequence Number: 7382015
• Product Code: DRE
• UDI-Device Identifier: 00827002044432
• UDI-Public: (01)00827002044432(17)250525(10)14751242
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 08/05/2022

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: 05/25/2025
• Device Model Number: N/A
• Device Catalogue Number: JCD22.0-38-20-COONS
• Device Lot Number: 14751242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 07/28/2022; 07/27/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 07/29/2022; 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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