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It was reported that a catheter from a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray clotted after a central line insertion procedure.
The patient had the clotted device removed and another central line needed to be placed.
The facility noted encounters with central venous catheters that had recently been placed and sent to x-ay for confirmation, only to discover that once the patient returned to the icu, the catheter had clotted off.
No images will be provided for the investigation, and no further information is available.
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Blank fields on this form indicate the information is unchanged, unknown or unavailable.
Investigation ¿ evaluation.
A review of documentation including the instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device was conducted during the investigation.
The complaint device was not returned; therefore, no physical examinations could be performed.
However, cook received a complaint for a similar product experiencing the same failure mode in another complaint (reported under mdr# 1820334-2018-03530).
A physical examination of the device found no kinks or damage.
A wire guide was inserted into the endhole and exited the red hub without difficulty.
A wire guide was inserted into the blue hub and wire was not visible in the sideport.
The blue lumen was noted to be occluded at the sideport.
A wire was inserted into the white lumen and passed to the sideport.
The blue lumen was flushed with some resistance experienced, as only drops of water came out.
The water droplets were noted to be dark brown with dark specs and debris.
The red lumen flushed brown and the white lumen flushed brown with specs.
Catheter shaft and extension tubing outer diameters were all measured within specification and the reported failure mode was able to be recreated.
Dark brown liquid with dark specs and debris came out during flushing which are an indication that this had occluded the lumen.
As the device was used, it is most likely that the observed matter is dried biological matter.
Because both this complaint and the related complaint have the same failure mode of occlusion in the lumen it is possible that the two events have a similar cause.
A document-based investigation evaluation was also performed.
It was concluded that the device aspect in question was visually and functionally inspected by quality control and no notable gaps in production or processing controls were noted.
The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.
Because adequate inspection activities have been established, it was concluded that there is no evidence that nonconforming product exists in house or in field.
The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: ¿if lumen flow is impeded, do not force injection or withdrawal of fluids.
Notify attending physician immediately.
¿ suggested catheter maintenance: ¿catheter entry site must be prepared and maintained in a manner consistent with standard procedure for central venous catheterization.
¿ ¿to prevent clotting or possibility of air embolus, the double-lumen¿s #2 lumen, and the triple-lumen¿s #2 and #3 lumens should be filled with saline solution or heparinized saline solution (100 units of heparin per cc of saline is usually adequate), depending on institutional protocol, prior to catheter introduction.
¿ ¿after catheter is placed and prior to use, tip position and lumen patency should be confirmed by free aspiration of venous blood.
If blood is not freely aspirated, physician should immediately reevaluate catheter tip position.
¿ ¿any unused lumens should be maintained with continuous saline or heparinized saline drip or locked with heparinized saline solution.
Heparin-locked lumens should be reestablished at least every 8 hours.
¿ ¿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.
¿ instructions for use: ¿prepare the catheter for insertion by flushing each of the lumens and clamping or attaching the injection caps to the appropriate extensions.
Leave the distal extension uncapped for wire guide passage.
¿ ¿after catheter is in position, remove wire guide.
Venous blood should be easily aspirated.
Winged hub can now be sutured into place.
If catheter is not introduced to its full length, additional suture should be carefully placed around catheter and affixed to the skin at entry site if movable suture wing is not included.
This will help prevent backward or forward catheter movement.
Lumens should now be flushed with 5-10 cc normal saline prior to use or establishment of heparin lock.
¿ how supplied¿ ¿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 the investigation, a definitive cause could not be established.
The appropriate personnel have been notified.
Cook will continue to monitor for similar complaints.
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.
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