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

Catalog Number C-UTLM-701J-ABRM-HC-RD-P

Device Problem Partial Blockage (1065)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.(b)(6).(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that the lumens of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set were getting blocked after placement.Consequently, "sampling and medication" were unable to be done through the catheter.The catheter was flushed "with heparin frequently and managed".It was also reported that an additional catheter was inserted to continue treatment.Additional information regarding the event and device has been requested but is unavailable at this time.

Manufacturer Narrative

Investigation - evaluation: it was reported to cook that the lumens of the catheter within a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set, c-utlm-701j-abrm-hc-rd-p, from lot # 9414574, became occluded.This failure was noted 2 days after placement.This incident was reported by dhanvantri critical care center in india on 03feb2020.No adverse effects were reported.A review of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control of the device was conducted.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot (9414574) and the related catheter and manifold sub-assembly lots revealed one non-conformance for "tip inadequate" in which one device was scrapped.A database search found one other event associated with the reported lot number from the same customer.Results from that investigation found no manufacturing-related issues.Given this information, cook cannot conclude that the product was not manufactured to specification or that non-conforming product exists either in house or in field.Although the complaint component is on a supplied part to cook, there is no evidence suggesting a manufacturing cause of failure.Due to this, no supplier investigation is necessary.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.¿ suggested 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, no product returned, and the results of our investigation, a definitive root cause was traced to component failure without a manufacturing or design deficiency.It is possible that a mixture between multiple medications could have caused a precipitate to form occluding the extension tubes, however this cannot be confirmed.Per the quality engineering risk assessment no further action is required.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 patient/event information 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: 9719928
• MDR Text Key: 192487937
• Report Number: 1820334-2020-00380
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002535992
• UDI-Public: (01)00827002535992(17)211010(10)9414574
• Combination Product (y/n): N
• PMA/PMN Number: K033843
• 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: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2021
• Device Catalogue Number: C-UTLM-701J-ABRM-HC-RD-P
• Device Lot Number: 9414574
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention