MAUDE Adverse Event Report: COOK INC ULTRATHANE COPE NEPHROURETEROSTOMY SET; LJE CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of the drawings, instructions for use (ifu), manufacturing instructions, specifications, trends and quality control was conducted during the investigation.The customer provided a photographic image of the device showing a separation of the hub from the catheter flange.No conclusion can be drawn from this image.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known, accordingly a review of the device history record could not be conducted.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

Customer reported that "the hub on the drain fell off during an mri.The drain was removed and replaced." the ultrathane cope nephroureterectomy drain was placed on an unspecified date and remained in-situ for three days before the event.The conditions and circumstances surround the event were not provided.Additional event and patient details were requested; no additional information was received.

• Brand Name: ULTRATHANE COPE NEPHROURETEROSTOMY SET
• Type of Device: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6335924
• MDR Text Key: 67580182
• Report Number: 1820334-2017-00170
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-26-NUCL-B-RH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• 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
• Patient Outcome(s): Required Intervention