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

Model Number N/A

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.Occupation: supply chain specialist.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 brown-colored liquid was noticed in the bottom of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set prior to use.The liquid was noticed after the device was opened.Additional information regarding the event has been requested but is currently unavailable.

Manufacturer Narrative

Investigation - evaluation: it was reported that upon opening a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set (c-utlm-701j-rsc-abrm-hc-rd-cah) from lot 13378439, a brownish liquid was observed in the tray.Cook became aware of this event on 20oct2020 upon being notified by (b)(6) hospital and clinic.The device did not make patient contact and there was no patient harm.A review of the instructions for use (ifu) and quality control of the device was conducted during the investigation.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 design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the device history record (dhr) for the reported complaint device lot (13378439) revealed no recorded non-conformances.A database search did not identify any other events associated with the reported device lot.Based on this information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.Instructions for use (ifu) document c_t_ctulmabrm_rev7 [cook spectrum and spectrum glide central venous catheters] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: ¿suggested catheter maintenance: the antimicrobial agents minocycline and rifampin contain yellow/orange pigments.Some coloration of the spectrum or spectrum glide catheters is normal.How supplied sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile¿.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 unable to be established.The source of the liquid is unclear based on the provided information.It is potentially related to the coating of the device, a liquid introduced during manufacturing, and/or a liquid introduced after the set was opened.However, none of these possibilities can be confirmed without additional information and/or physical examination of the complaint device.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.

Event Description

Additional information was received on 15jan2021.The liquid in the tray was noticed right when the device was opened and there was no patient harm reported.

• 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: 10847651
• MDR Text Key: 219533988
• Report Number: 1820334-2020-02104
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/02/2023
• Device Model Number: N/A
• Device Catalogue Number: C-UTLM-701J-RSC-ABRM-HC-RD-CAH
• Device Lot Number: 13378439
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1