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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 510k status: exempt.(b)(4).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
The customer reported that the hub off the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was "leaking once we inserted and because of the leak, the device had to be replaced." there was no report of an adverse event.Additional information has been requested from the customer, but none has yet been provided.The device was received for evaluation; however, as of the date of this report, the investigation is still pending.
Additional Manufacturer Narrative
Additional information: device evaluated by mfr.Corrected information: report source.Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control, and functional testing of the returned device was conducted during the investigation.One catheter was returned with the catheter cut several centimeters from the hub.The cap and tubing was unable to be tugged or twisted within the proximal assembly.Biomatter was present.The mac-loc was returned in the locked position.No cracks or defects were observed on the proximal assembly.One thread was present between the mac-loc and cap.Hemostats were used to clamp off the catheter in order to pressurize the proximal assembly.A pressure of 8.5psi was held for approximately 2min with no water leaking.Therefore, the failure mode could not be duplicated.However, it is possible that the hub initially leaked and the biomatter dried causing the leak to stop.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Review of the device history record shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the provided information, inspection of returned product and the results of the investigation, a definitive root cause could not be determined.Measures have been initiated to address this failure mode.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 DAWSON-MUELLER 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: 7204674
• Report Number: 1820334-2018-00053
• Device Sequence Number: 135322
• Product Code: GBO
• UDI-Device Identifier: 00827002104358
• UDI-Public: (01)00827002104358(17)200718(10)8074810
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/20/2018

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 Model Number: N/A
• Device Catalogue Number: ULT12.0-38-25-P-5S-CLDM-HC
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 01/18/2018
• Supplement Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1