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 Complete Blockage (1094)

Patient Problem No Code Available (3191)

Event Date 12/17/2019

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 after placing a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set, the lumens were becoming blocked, making it impossible to administer medication to the patient and complete sampling through the catheter.Consequently, an additional catheter was inserted to continue treatment "in some cases".It was also reported that "they flushed frequently with heparin and managed".Additional information regarding the event and device has been requested but is unavailable at the time of this report.

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.

Event Description

In additional information received on 03feb2020, it was reported that the catheters were in place for 2 days after placement.The line was being used for medication infusion and blood sampling.The facility reported that the lumens were flushed with heparin in every procedure and "used our lock only.".

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.H6 ¿ method code: (4114) device not returned.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 (b)(6), in india, on 10jan2020.No adverse effects were reported.A review of documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control of the device was conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.A review of the device history file for lot 9414574 revealed one relevant nonconformance for "tip inadequate", in which all nonconforming products were scrapped.It should be noted that there was one other complaint reported for this lot number, in which the complaint originated from the same facility for an additional patient (mfg.Report reference #: 1820334-2020-00380).There is no evidence suggesting a manufacturing cause of the failure or that 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 lumen utilization: triple-lumen: ¿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; middle exit port ¿ medication delivery; acute hyperalimentation; 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, no returned product and the results of our investigation, the cause could be traced to a 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.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
• 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: 9611543
• MDR Text Key: 189470587
• Report Number: 1820334-2020-00175
• 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: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• 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