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

Model Number G55801

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2022

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Customer name and address= phone: (b)(6).Occupation: product supervisor.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 Description

As reported, a cook distributor discovered something/unknown in the package of a universa loop nephrostomy percutaneous drainage catheter.A picture was provided that appears to show a hair like fiber inside the package of the device.The issue was discovered at the distributor's site and there was no patient involvement.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, a cook distributor discovered something/unknown in the package of a universa loop nephrostomy percutaneous drainage catheter.A picture was provided that appears to show a hair like fiber inside the package of the device.The issue was discovered at the distributor's site and there was no patient involvement.Investigation ¿ evaluation reviews of the complaint history, device history record, instructions for use, and quality control procedures, as well as a visual inspection of the device were conducted during the investigation.One universa loop nephrostomy percutaneous drainage catheter was returned in an unopened, labeled package.A long dark hair was found in the sealed package.A review of the device history record found no non-conformances related to the reported failure mode.No additional complaints were received for this product lot.Due to the individual nature of inspecting the finished packaged product, one nonconformance does not indicate additional nonconformances in the lot.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of manufacturing procedures found controls to be in place to identify this failure mode prior to distribution.The packaged product are visually inspected for foreign matter.The device is provided with instructions for use which state, " how supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened and undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred." based on the available information, cook has concluded that the cause of the complaint is manufacturing related.The employee who inspected the product for foreign matter has completed defect awareness training.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.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
• Type of Device: 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 ; 8128294891
• MDR Report Key: 15856159
• MDR Text Key: 307635034
• Report Number: 1820334-2022-01769
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• PMA/PMN Number: K140085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

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
• Device Expiration Date: 11/13/2023
• Device Model Number: G55801
• Device Catalogue Number: ULCS-8-30
• Device Lot Number: NS13555668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 01/09/2023
• Supplement Dates FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1