MAUDE Adverse Event Report: COOK INC UNIVERSA FIRM URETERAL STENT SET; FAD STENT, URETERAL

Model Number G49866

Device Problem Unsealed Device Packaging (1444)

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

Event Date 12/21/2021

Event Type  malfunction  

Event Description

As reported, the inner packaging of a universa firm ureteral stent set was not sealed properly.There was no patient impact as this event occurred prior to patient contact.

Manufacturer Narrative

(b)(6).A follow up report will be submitted should additional relevant information become available.

Event Description

Information received on 22dec2021 but was inadvertently omitted from the previous report.The procedure was completed with another device.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.H3 (other)(81): device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary as reported, the inner packaging of a universa firm ureteral stent set was not sealed properly.There was no patient impact as this event occurred prior to patient contact.The procedure was completed with another device.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, manufacturing instructions, and quality control data.A device failure analysis was conducted on the returned device.The product was returned in unopened packaging.The inner pouch for the positioner was not sealed properly.The bottom seal was diagonal instead of straight across the bottom of the package.In response to this incident, cook completed a review of the device history record (dhr) for the reported device lot.The dhr records one non-conformance, but this recorded nonconformance was deemed by cook to not be relevant to the reported failure mode.A trackwise search for complaints associated with the device lot was performed.No other complaints concerning that product lot were found.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: ¿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.¿ the complaint, reported by the customer, of the inner pouch being improperly sealed was confirmed by customer testimony and examination by cook.The manufacturing operator who sealed the packages for the lot is no longer with cook.Defect awareness training for the two quality control operators who oversaw the sealing of the lot was requested and completed as a result of this complaint.It was also confirmed that both operators were trained to to the proper standards at the time of the work order completion.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database 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.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• 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: 13194978
• MDR Text Key: 284132324
• Report Number: 1820334-2022-00031
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002498662
• UDI-Public: (01)00827002498662(17)240615(10)14026893
• Combination Product (y/n): N
• PMA/PMN Number: K161236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2022

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 Model Number: G49866
• Device Catalogue Number: UFH-526
• Device Lot Number: 14026893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 12/22/2021; 04/08/2022
• Supplement Dates FDA Received: 01/18/2022; 04/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2021
• 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