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	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The 510k status: 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
The customer reported that, during the middle of the night on (b)(6) 2018, when the patient was walking back from the bathroom to their bed, the hub of the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter which was placed on (b)(6) 2018 as a chest tube in the right pleural space, separated from the catheter portion of the device.As a result, the catheter had to be replaced in another procedure.No further device issues were reported.The complaint product is not available for return and evaluation.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, drawing, manufacturing instructions, quality control, and specifications of the device was conducted during the investigation.Clinical assessment: without visual, dimensional, and/or functional testing of the product, we are unable to rule out if this event was related to a manufacturing issue.At this time, clinical assessment cannot eliminate any possible causes for the separated hub such as product handling, patient behavior, patient environment, patient mobility, other device compatibility, device maintenance, device failure, or manufacturing related causes.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.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, the possible root cause is manufacturer related.This failure mode has been escalated per internal processes.The appropriate personnel have been notified, and this failure mode will continue to be trended.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 7343986
• Report Number: 1820334-2018-00720
• Device Sequence Number: 1741007
• Product Code: GBO
• UDI-Device Identifier: 00827002097063
• UDI-Public: (01)00827002097063(17)200627(10)8022090
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT10.2-38-25-P-5S-CLDM-HC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention