MAUDE Adverse Event Report: COOK INC COOK SPECTRUM; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.(b)(6).Occupation: regulatory affairs specialist.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
Upon receiving a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set reported under mdr # 1820334-2020-00464, it was discovered that the white hub of the device was occluded.The device was placed in the patient's subclavian vein and was being used to administer inotropes, fluids, and sedation treatments.No adverse effects to the patient have been reported.Additional information regarding specifically the white lumen/hub of the device has been requested but is currently unavailable.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation it was discovered that a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set (c-utlm-701j-lsc-abrm-hc-rd) from lot 9655662 had an occluded white hub.Cook became aware of this event on 04mar2020 upon testing of a returned device from mfg.Report reference #: 1820334-2020-00464.The patient reportedly experienced no adverse effects as a result of this incident.A review of documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control, as well as a visual inspection and functional test of the returned device was conducted during the investigation.One 7fr triple lumen central venous catheter was returned used, with biological matter present throughout the device.The blue hub is cracked through the number ¿2¿ stamped on the hub.A leak test was performed and confirmed leakage at the blue hub.Non-cook connector caps were attached to the red and blue hubs.A red cap was attached to the white hub.All caps were easily removed from the hubs.The red lumen was flushed without difficulty.The white lumen would not flush on the first attempt.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient controls are in place to detect this failure mode prior to release.A review of the design history file (dhf) found that the affected product is safe and effective for its intended use.A review of the device history records (dhr) for lot 9655662,as well as related catheter subassembly lots showed no related nonconformances that could have contributed to the reported failure mode.It should be noted that there was one other complaint associated with this lot was associated with a different failure mode.Since there are no related nonconformances or other complaints for the same failure mode from this lot, there is no evidence that no nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: "suggested catheter maintenance.¿ to prevent clotting or possibility of air embolus, the double-lumen¿s #2 lumen, the triple-lumen¿s #2 and #2 lumens, and the five-lumen¿s #2, #3, #4, and #5 lumens should be filled with saline solution or heparinized saline solution (100 units of heparin per ml of saline is usually adequate), depending on institutional protocol, prior to catheter introduction.¿ any unused lumens should be maintained with continuous saline or heparinized saline drip or locked with heparinized saline solution.¿ before using any lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumens should be flushed with normal saline between administrations of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin lock.".Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a component failure unrelated to manufacturing and design deficiencies contributed to the device failure.It is likely that biological matter comprised the occlusion.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We 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.

• Brand Name: COOK SPECTRUM
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9849610
• Report Number: 1820334-2020-00644
• Device Sequence Number: 16329415
• Product Code: FOZ
• UDI-Device Identifier: 00827002478251
• UDI-Public: (01)00827002478251(17)220206(10)9655662
• Combination Product (Y/N): N
• PMA/510(K) Number: K081113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 02/06/2022
• Device Model Number: N/A
• Device Catalogue Number: C-UTLM-701J-LSC-ABRM-HC-RD
• Device Lot Number: 9655662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1