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

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device name: cook spectrum minocycline / rifampin impregnated double lumen central venous catheter tray.Occupation: district manager.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 during dressing changes, the cook spectrum minocycline/rifampin impregnated double lumen central venous catheter comes out because the line is not long enough.The customer indicated that this has occurred more than once.As reported, no adverse effects have been experienced by the patients.Additional information regarding event details have been requested, but is unavailable at this time.

Event Description

No new event description information to report at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation - evaluation.A review of documentation including the drawing, instructions for use (ifu), manufacturing instructions and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, a physical examination of the product could not be conducted.However, a similar complaint for a similar device was referenced.The physical examination of the device from the referenced complaint found that the catheter tubing was confirmed to be too short.It was also found that the manifold was stamped with the wrong measurement.The investigation found that this event was due to a manufacturing and quality deficiency.Due to the similarities between the products and failures, it is possible that the two events have a similar cause.Additionally, 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.It was found that adequate risk mitigation activities are in place to capture potential failure modes prior to customer release.A review of the device history record could not be conducted, as the lot information was not provided.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 our investigation, it is possible that a manufacturing and quality deficiency contributed to the event.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified and we 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.

• 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: 8892822
• MDR Text Key: 154272500
• Report Number: 1820334-2019-02012
• Device Sequence Number: 1
• Product Code: FOZ
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-UDLMY-401J-PED-ABRM-HC-FST
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Patient Sequence Number: 1