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

Model Number N/A

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

Device name: cook spectrum minocycline / rifampin impregnated triple lumen central venous catheter set.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that on (b)(6) 2019, the physician discovered during a femoral vein procedure that two of three hubs on a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set were occluded.After placement, the physician discovered that the red hub was the only one that was not occluded.The catheter was flushed to test its performance before the procedure and yielded satisfactory results.Additional information regarding device details has been requested but is unavailable at the time of this report.No adverse events or patient harm have been reported at this time.

Manufacturer Narrative

H6 - results code: occluded hubs.Investigation - evaluation.A review of documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions (mi), and quality control, as well as a visual inspection and functional test of the returned device was conducted during the investigation.One used device was returned for investigation.Upon a physical examination, excessive biological matter was observed though no surface damage to the extension tubes, hubs, or manifold was noted.The blue and red hubs allowed a wire guide to pass through, but the white hub failed to do so.All hubs were able to be flushed, but the red hub showed resistance.There is no evidence suggesting that the device was manufactured out of specification.The complaint was able to be confirmed based on customer's testimony and the returned device.Additionally, a document-based investigation evaluation was performed.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record for lot 9166947 found no related non-conformances.A database search found no additional complaints for the provided lot.Due to this information, there is no evidence suggesting that nonconforming product from this lot exists in house or in field.Cook also reviewed product labeling.The product ifu, [c_t_ctulmabrm_rev7] ¿cook spectrum central venous catheter minocycline/rifampin antibiotic impregnated power injectable, provides the following information to the user related to the reported failure mode: suggested lumen utilization: triple-lumen: #1 distal exit port (end hole) ¿ whole blood or blood product delivery and sampling; any situation requiring more flow rate; cvp monitoring; medication delivery; power injection studies.It is strongly recommended that this lumen be used for all blood sampling.¿ct¿ labeled on the distal #1 lumen hub indicates that this is the lumen which should be utilized for power injection.#2 middle exit port ¿ medication delivery; acute hyperalimentation.#3 proximal exit port ¿ medication delivery.Suggestd catheter maintenance: to prevent clotting or possibility of air embolus, the double-lumen¿s #2 lumen, the triple-lumen¿s #2 and #3 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.How supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, examination of the returned product, and the results of our investigation, a definitive root cause can be traced to component failure without a manufacturing or design deficiency.It is also possible that improper maintenance of the device could have caused the reported failure.Per the quality engineering risk assessment no further action is required.The appropriate personnel have been notified.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COOK SPECTRUM
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8940658
• MDR Text Key: 156740459
• Report Number: 1820334-2019-02150
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002478299
• UDI-Public: (01)00827002478299(17)210627(10)9166947
• Combination Product (y/n): N
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2021
• Device Model Number: N/A
• Device Catalogue Number: C-UTLM-701J-RSC-ABRM-HC-RD
• Device Lot Number: 9166947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 46