MAUDE Adverse Event Report: COOK INC UNKNOWN

Catalog Number UNKNOWN

Device Problem Obstruction of Flow (2423)

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

Event Date 10/26/2018

Event Type  malfunction  

Manufacturer Narrative

Common name & product code: unavailable as the device lot number, rpn, and gpn are unknown.Occupation: clinical product evaluation coordinator.Pma/510(k) number: unavailable as the device lot number, rpn, and gpn are unknown.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 lumen of a cook cvc catheter used to administer long term fluid and medication occluded.The medial port of the central venous catheter occluded during the night shift.As a result, the night shift registered nurse moved the drips to the proximal lumen of the catheter.At 07:30 the device was assessed for blood return and then flushed.The infusion continued to work until 13:15, when the total parenteral nutrition (tpn) pump alarmed "occluded patient side".The registered nurse restarted the infusion.The tpn pump alarmed "occluded patient side" again.The nurse attempted to flush the catheter lumen and was unable to do so.The physician was at bedside.Additional information was requested regarding the event and patient outcome but is not available at the time of this report.

Event Description

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

Manufacturer Narrative

D10: product received on: 18apr2019.Investigation/evaluation: a review of the complaint history, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.The complainant returned one cvc in a used condition.Tape was present on the blue #2 hub with the writing "do not use".We measured device attributes and found them all to be within manufacturing specifications.We flushed all the lumens in an attempt to find the occlusion.The white lumen was flushed with no difficulty.The red lumen was unable to be flushed, indicating a blockage.Part of the red lumen blockage was removed by flushing with force, causing a yellow liquid to come out of a distal sideport.The blue lumen was unable to be flushed, indicating a blockage.It is likely that the biomatter at the distal sideports was contributing to the blockage of the red and blue lumens.Investigators could recreate the reported failure mode.The device was obstructed but there was no evidence to suggest that the device was not manufactured to current specifications.The complainant did not provide the device lot number for investigation.Without further information we are unable to identify the complaint device or complaint device lot.Therefore, there is no evidence to suggest all items in the lot or similar devices in house or in the field are non-conforming.If the lot number becomes available, cook will evaluate the device history record, review the complaint history, and update the file at that time.Based on the review of current documentation, cook has concluded that sufficient controls and inspections are in place to prevent the release of non-conforming product related to the reported failure mode.Based on the information provided, inspection of returned product and the results of the investigation, cook has concluded that the failure mode for the device complaint was obstructed lumen.A definitive conclusion as to why the lumens became occluded cannot be drawn.It is possible that the catheter was not maintained properly, leading to accumulated biomatter and occluding of the line at the sideports.This cannot be confirmed though.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.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.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8440708
• MDR Text Key: 139728089
• Report Number: 1820334-2019-00681
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1