MAUDE Adverse Event Report: COOK INC MODIFIED NOVY CORNUAL CANNULATION SET; MOV CATHETER, SALPINGOGRAPHY

Model Number	G17558
Medical Device Problem Codes	Material Discolored (1170); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the modified novy cornual cannulation set pouch was visibly yellow (foreign matter is identified within the device or packaging), this issue was discovered prior to package being opened and it was not used on a patient.The initial reporter believed the device may have been contaminated due to yellow pouch and opted not to use the device.The procedure was completed by using another new device.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
G4: pma/510(k) #: k180552.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.
Additional Manufacturer Narrative
Correction: b1, h1: this report is being sent to indicate the complaint event is not reportable under fda 21 cfr part 803.As such, this event no longer meets the set criteria for a reportable event; no further reports regarding this event will be submitted.Corrected information: h6: annex a.The device was received 04dec2024: yellow tint is visible on chevron end of package.Appears the package was exposed to light for long periods of time.Furthermore, there is no evidence that the device caused or contributed to a serious injury or patient death.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.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: MODIFIED NOVY CORNUAL CANNULATION SET
• Common Device Name: MOV CATHETER, SALPINGOGRAPHY
• 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: 20757577
• Report Number: 1820334-2024-01535
• Device Sequence Number: 8587226
• Product Code: MOV
• UDI-Device Identifier: 00827002175587
• UDI-Public: (01)00827002175587(17)260210(10)15217711
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2024

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: 02/10/2026
• Device Model Number: G17558
• Device Catalogue Number: J-NCS-504070
• Device Lot Number: 15217711
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• 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