MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET; FGE, STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	G10049
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	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2a - common device name: additional names: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy.D2b - procode: additional product codes: gbo, lje.H3 - device evaluated by mfg? device evaluation anticipated but has not yet begun.Awaiting device return.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 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 or that a death or serious injury occurred; nor is it admission 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
It was reported that an ultrathane mac-loc locking loop multipurpose drainage set had foreign matter within the packaging.As reported, the device did not make patient contact.
Additional Manufacturer Narrative
Additional information: d9 investigation ¿ evaluation it was reported that an ultrathane mac-loc locking loop multipurpose drainage set had foreign matter within the packaging.As reported, the device did not make patient contact.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.One sealed and unused device was returned to cook for evaluation.A visual examination confirmed that foreign matter (small white particles, along with one dark colored foreign body of unknown origin) was noted sealed inside the tray, near the bottom of the tray.The pouch was opened, and the foreign bodies were confirmed to be on the tray that was inside the pouch, not on the device itself.Cook has concluded that the device was manufactured out of specification.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 dhrs for the reported complaint device lot did not reveal any quality control discrepancies.A complaint history search did not identify any other events associated with the reported device lot.An expanded search was conducted within the packaging department, focusing on other lots processed during the same timeframe.This search identified three additional lots.No complaints have been reported for these lots regarding foreign matter.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming products exist either in house or in field.Cook also reviewed product labeling.The ifu supplied with the device states the following in consideration of the reported failure mode: how supplied: upon the removal from the package, inspect the product to ensure no damage has occurred.Based on the available information, inspection of the returned device, and the results of the investigation, cook has concluded that the main cause of failure is manufacturing related.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 or that a death or serious injury occurred; nor is it admission 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: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE SET
• Common Device Name: FGE, STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS
• 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 jason ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 22965077
• Report Number: 1820334-2025-01104
• Device Sequence Number: 15718826
• Product Code: FGE
• UDI-Device Identifier: 00827002100497
• UDI-Public: (01)00827002100497(17)280528(10)16589731
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K173035
• 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): 03/12/2026

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: G10049
• Device Catalogue Number: CLM-8.5-RH-NPAS-NT
• Device Lot Number: 16589731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown