MAUDE Adverse Event Report: COOK INC ULTRAXX NEPHROSTOMY BALLOON AND SET; LJE CATHETER, NEPHROSTOMY

Catalog Number UNBS-6-15-CS

Device Problem Contamination (1120)

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

Event Type  malfunction  

Event Description

As reported, there was a hair-like matter in the packaging of a ultraxx nephrostomy balloon and set.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Customer name/address/phone = unknown.Customer occupation = unknown.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, 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.

Manufacturer Narrative

Summary of event: as reported, there was a hair-like matter in the packaging of a ultraxx nephrostomy balloon and set.The patient did not experience any adverse effects due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.A visual inspection was also conducted.The packaging for one ultraxx nephrostomy balloon and set was returned with no product for investigation.The product lot number indicated on the packaging label matched the complaint device lot number.The packaging was open, and a long hair was loose inside of the packaging.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.The product ifu provides the following information: 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 due to the individual nature of inspecting the packaged product, one nonconformance does not indicate additional nonconformances in the lot.Additionally, there have been no other complaints filed for this lot.Therefore, there is no evidence to suggest that nonconforming product are in the field.A review of relevant manufacturing and quality control documents were conducted.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of manufacturing procedures found controls to be in place, the packaged products are visually inspected for foreign matter.Cook has concluded that manufacturing is likely the cause for the complaint.The risk analysis for this failure mode was reviewed and no additional escalation is required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 Description

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

• Brand Name: ULTRAXX NEPHROSTOMY BALLOON AND SET
• 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 ; 8123392235
• MDR Report Key: 15841228
• MDR Text Key: 307980281
• Report Number: 1820334-2022-01757
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• PMA/PMN Number: K024050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2023

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 Operator: Health Professional
• Device Catalogue Number: UNBS-6-15-CS
• Device Lot Number: 14754309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 12/29/2022
• Supplement Dates FDA Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2022
• 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