MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number	N/A
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: purchasing manager.Initial reporter also sent report to fda: unknown.Pma/510(k) #: exempt.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 reported an ultrathane mac-loc locking loop multipurpose drainage catheter was placed for an unspecified drainage procedure.When drawing the fluid during the procedure, air was discovered to be drawing as well.It is unknown whether the device was replaced to complete the procedure.Although requested, additional details regarding the event, patient outcome and device return are unavailable.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.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 catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record revealed one nonconformance in lot 8691270, in which two devices were scrapped for an incorrect suture routing, as the suture could not be seen at the fitting.Eight devices were scrapped in the catheter tubing subassembly lot sa8594771 for foreign matter.It should be noted that there were no other complaints reported for lot 8691270.The instructions for use (ifu) advise the user to inspect the product prior to use to ensure that no damage has occurred.Based on the information provided, no returned product and the results of our investigation, a definitive cause could not be established.Appropriate measures have been taken 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.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER
• Common Device Name: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8015607
• Report Number: 1820334-2018-03290
• Device Sequence Number: 1368608
• Product Code: GBO
• UDI-Device Identifier: 00827002095045
• UDI-Public: (01)00827002095045(17)210324(10)8691270
• 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): 12/31/2018

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: 03/24/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT14.0-38-25-P-6S-CLM-RH
• Device Lot Number: 8691270
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 12/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1