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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer (person): initial reporter is a charge tech at (b)(6) hospital occupation: charge tech.Pma/510(k) #: preamendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was discovered during manufacturer bench testing that a previously unopened, returned ultrathane cope nephroureterectomy set leaked.The unopened products were returned as a result of a previously reported leak captured under mdr #1820334-2018-03288.The device did not make patient contact.No adverse events are associated with this event.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation - evaluation.A review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, inspection of unused product, quality control, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.The visual inspection confirmed the device was unused and sealed in the packaging.All device components were measured within the correct specifications and tolerances.Leakage was observed during the functional test at the junction between the catheter tubing and connector cap.Additionally, a document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record found two related non-conformances with the device lot.There is 100% inspection for these nonconformances prior to release and all four nonconforming devices were scrapped.It should be noted that there were four other complaints reported for this lot from the same customer.Based on the information provided, the examination of returned product, and the results of the investigation, a definitive root cause could not be established.Appropriate measures are being conducted to address this failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 8271304
• Report Number: 1820334-2019-00181
• Device Sequence Number: 13973549
• Product Code: LJE
• UDI-Device Identifier: 00827002481664
• UDI-Public: (01)00827002481664(17)210129(10)8544564
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-10.2-26-NUCL-B-RH
• Device Lot Number: 8544564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1