MAUDE Adverse Event Report: COOK INC UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER; LJE CATHETER, NEPHROSTOMY

Model Number	G55802
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: customer name: (b)(6).E3: customer occupation = purchasing.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 in the universa loop nephrostomy percutaneous drainage catheter's sealing package contained foreign matter (a hair) prior to an unspecified procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The device did not make patient contact.Additional information has been requested but is unavailable at this time.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Correction: d9, d3 (email), g1 (contact and mfg site email) and h3.H3: not returned to the manufacturer investigation ¿ evaluation it was reported in the universa loop nephrostomy percutaneous drainage catheter's sealing package contained foreign matter (a hair) prior to an unspecified procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The device did not make patient contact.Reviews of documentation including the complaint history, device history record (dhr), quality control (qc) procedures, and instructions for use (ifu), were conducted during the investigation.The complaint device was not returned to cook for investigation; therefore, no physical examinations could be performed.The customer has confirmed that the product was shipped but it was not received by cook.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 device history record (dhr) found no related non-conformances that could have contributed to the reported failure mode.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device lot.Cook also reviewed product labeling.The ifu packaged with the device contains the following in relation to the reported failure mode: how supplied '.Do not use the product if there is doubt as to whether the product is sterile.' based on the available information, no product returned, and the results of the investigation, cook has concluded that the cause of the foreign matter said by the customer to be hair and is likely due to a manufacturing error.Complaint awareness training has been completed for the relevant personnel tasked with quality control of packaging for this lot.The appropriate personnel have been notified, and cook will continue to monitor for similar events.Per the quality engineering 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.

• Brand Name: UNIVERSA LOOP NEPHROSTOMY PERCUTANEOUS DRAINAGE CATHETER
• Common Device Name: LJE CATHETER, NEPHROSTOMY
• 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: 20880149
• Report Number: 1820334-2024-01618
• Device Sequence Number: 12671714
• Product Code: LJE
• UDI-Device Identifier: 00827002558021
• UDI-Public: (01)00827002558021(17)270228(10)15924185
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: G55802
• Device Catalogue Number: ULCS-10-30
• Device Lot Number: 15924185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown