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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The customer reported that the hub of the device separated.The device was originally placed on (b)(6) 2017.The separation occurred on (b)(6) 2017, and it necessitated the removal and replacement of the device.No further complications were reported.
Additional Manufacturer Narrative
Corrected information: the device was originally placed on (b)(6) 2017.User facility, company representative.Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, and quality control data was conducted during the investigation.A review of the device history record for the lot in question revealed two non-conformances; however this product was scrapped prior to completion of the finished lot.There have been no other complaints in reference to this lot number.The complaint device was not returned; therefore, no physical examination and testing could be performed.However, an image was included in the complaint which showed the mac-loc assembly and connector cap separated from the flared tubing outside of the patient.However, with the photo alone, we were unable to determine if the tubing flare was too small.Based on the information provided, the results of our investigation, and without visual inspection of the affected device and dimensional measurement of the tubing flare, we are unable to determine with certainty the root cause.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: ULTRATHANE COPE NEPHROURETEROSTOMY SET
• Common Device Name: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6816211
• Report Number: 1820334-2017-02537
• Device Sequence Number: 18866679
• Product Code: LJE
• UDI-Device Identifier: 00827002481763
• UDI-Public: (01)00827002481763(17)191121(10)7461454
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-8.5-24-NUCL-B-RH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 12/05/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention