MAUDE Adverse Event Report: COOK INC ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G06990
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2a: additional common name: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy; lje catheter, nephrostomy d2b: additional product code: gbo; lje.G4: pma/510(k) #: k173035.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 the inner packaging of an ultrathane ring biliary duct drainage catheter was found to be unsealed.At this time, no adverse effects or additional procedures for the patient were reported due to this occurrence.
Event or Problem Description
This event no longer meets the qualifications for a reportable event.See h10.
Additional Manufacturer Narrative
Correction: this report is being sent to indicate the complaint event is not reportable.The device was received on 05nov2024.Upon investigation, it was discovered that all the seals were present and intact.However, the packing was torn and discolored.There is no evidence to suggest that the observed device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury took place, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.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.

• Brand Name: ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• 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: 20464539
• Report Number: 1820334-2024-01340
• Device Sequence Number: 12953867
• Product Code: FGE
• UDI-Device Identifier: 00827002069909
• UDI-Public: (01)00827002069909(17)270830(10)16231464
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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 Model Number: G06990
• Device Catalogue Number: ULT12.0-38-50-P-32S-RING
• Device Lot Number: 16231464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2024
• 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