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

Model Number G55803

Device Problem Unsealed Device Packaging (1444)

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

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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.

Event Description

As reported, the package of a universa loop nephrostomy percutaneous drainage catheter was found unsealed.The issue was discovered by a cook distributor during their receiving and inspection process.There was no patient involvement.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: as reported, the package of a universa loop nephrostomy percutaneous drainage catheter was found unsealed.The issue was discovered by a cook distributor during their receiving and inspection process.There was no patient involvement.Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), the instructions for use (ifu), and quality control procedures.One universa loop nephrostomy percutaneous drainage catheter was returned for investigation.The outer package the product was returned in, was open at the thumb hole end.The seal marks were not visible indicating that the package was not sealed during manufacturing.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 found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.The cause of the complaint was likely due to a manufacturing and quality control error.Both manufacturing and quality control operators have been made aware of the customer complaint.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.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

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

• 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 ; 8123392235
• MDR Report Key: 17126505
• MDR Text Key: 317906396
• Report Number: 1820334-2023-00748
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002558038
• UDI-Public: (01)00827002558038(17)260202(10)15204319
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/07/2023

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 Model Number: G55803
• Device Catalogue Number: ULCS-12-30
• Device Lot Number: 15204319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• 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