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

Catalog Number C-UDLM-401J-ABRM-HC

Device Problem Obstruction of Flow (2423)

Patient Problem No Code Available (3191)

Event Date 08/30/2018

Event Type  Injury  

Manufacturer Narrative

Brand name: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter set.(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 a cook spectrum minocycline/rifampin impregnated double lumen central venous catheter was found to be occluded.The device was removed and discarded and a like device from the same lot was placed in the right femoral vein.This device was found to be occluded after insertion and was removed.A third device from the same lot was placed in the left femoral vein with no incident to complete the procedure successfully.As reported, the patient did not experience any adverse effects due to this occurrence and is in stable condition.

Manufacturer Narrative

Blank fields on this form indicate the information has previously been reported, is unknown or is unavailable.Device evaluation: one catheter was returned for testing (the other was discarded by the customer).Functional testing and visual inspection were performed and found the device to be within specification.The catheter was found to be unobstructed.The reported failure could not be duplicated.Additionally, a document based investigation evaluation was performed.Investigation: a document-based investigation reviewed the following: instructions for use, quality control specifications, manufacturing instructions, complaint history and device history records.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no notable gaps in production or processing controls were noted.A review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Therefore, there is no indication from the device history record that there is nonconforming product in the field.Ifu states: do not cut, trim or modify catheter or components prior to placement or intraoperatively.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 sale 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 during normal saline before reestablishing heparin lock." clinical assessment: based on current information, the most probable causes of this event are medical procedure, human anatomy and/or device failure related.The risk specification for this product includes the insufficient flow failure mode and identifies that multiple risk controls are in place to mitigate the risk of this type of failure.Conclusion: per the [quality engineering] risk assessment, no further action is required.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Based on the information provided, examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.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

No new event description information to report at this time.

• 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: 7894518
• MDR Text Key: 120893454
• Report Number: 1820334-2018-02697
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002439832
• UDI-Public: (01)00827002439832(17)200628(10)8245933
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Catalogue Number: C-UDLM-401J-ABRM-HC
• Device Lot Number: 8245933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 3