MAUDE Adverse Event Report: COOK INC DRETLER UNIVERSAL URETEROSCOPY STENT SET; FAD STENT, URETERAL

Model Number G17813

Device Problems Detachment of Device or Device Component (2907); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 02/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510k #: k181971.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, prior to the distributor delivering a dretler universal ureteroscopy stent set to the hospital, they noticed a black foreign substance.The foreign substance appears to be a ring.The device was not sent to the hospital, but they plan to deliver another same type device.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.B1, h1: on return of device (b)(6) 2022, the reported foreign object was identified as an o-ring component of the male luer lock adapter.The male luer lock adapter had come apart within the well of the packaging tray.The adapter was reassembled during evaluation, and the o-ring fit in its intended location securely within the adapter.There is no evidence to suggest that the observed device failure would be likely to cause or contribute to a death or a serious injury if the failure were to recur.Furthermore, there is no evidence that the device caused or contributed to a serious injury, as no life-threatening or permanently impairing injury took place, nor was intervention taken as a result of the device failure which would be required to prevent permanent impairment or damage to the patient.As such, the event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury, or reportable product malfunction.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: DRETLER UNIVERSAL URETEROSCOPY 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 ; 8123392235
• MDR Report Key: 13577774
• MDR Text Key: 291235360
• Report Number: 1820334-2022-00277
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002178137
• UDI-Public: (01)00827002178137(17)241119(10)14366643
• Combination Product (y/n): N
• 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: 03/18/2022

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 Model Number: G17813
• Device Catalogue Number: 025508-I
• Device Lot Number: 14366643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 02/22/2022
• Supplement Dates Manufacturer Received: 03/11/2022
• Supplement Dates FDA Received: 03/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2021
• 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