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

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Device name: cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray.Additional pro code: ljs.Occupation: 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 an unknown component of the cook spectrum minocycline/rifampin impregnated double lumen central venous catheter tray broke/fractured.Information regarding event details and patient outcome have been requested, but is unavailable at this time.

Event Description

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

Manufacturer Narrative

Investigation/evaluation: a review of documentation including the complaint history, instructions for use (ifu), quality control and drawing of the device was conducted during the investigation.The complaint device was not returned, therefore no physical examination 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.A review of the device history record could not be completed due to unknown lot information.A search was completed for all lots on the reported rpn sold to the customer during the time frame 3 years prior to the incident (01jan2016-13jun019), however a manageable suspected lot list could not be produced.A search for complaints reported on these lots found no additional complaints reported from the field.There is no evidence to suggest 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: 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 the investigation, a definitive cause could not be established.Appropriate measures have been taken to address this failure mode.Cook will continue to monitor for similar complaints.The appropriate personnel have been notified.Per 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.

• 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: 8759882
• MDR Text Key: 150029441
• Report Number: 1820334-2019-01612
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K021557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: C-UDLMY-801J-ABRM-HC-FST-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1