MAUDE Adverse Event Report: COOK INC UNKNOWN

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: consultant.(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 that the hub of an unknown cook central venous catheter cracked, resulting in the patient requiring device replacement.The complaint device was not placed at the reporting facility.No other adverse effects have been reported.Additional information regarding the patient, device, and event has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.B3- date of event: the event occurred "several weeks ago".This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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

In additional information received on 02dec2020, it was reported that the event occurred during a routine home visit with a nurse.The extension tubing "snap[ped] off inside the catheter hub", rendering the device unusable.

Manufacturer Narrative

Investigation - evaluation.It was reported that an unknown central venous catheter cracked at the hub.The extension tube connected to the hub later snapped off and the line had to be replaced.Cook became aware of this event on 11nov2020 upon being notified by a homecare nurse.No additional information is available regarding the procedure, device, or patient.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) could not be completed due to a lack of lot information from the user facility.Given this information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.C_t_ctulmabrm_rev7 [cook spectrum central venous catheter minocycline/rifampin antibiotic impregnated power injectable] is packaged with the assumed rpn of this device.The product ifu states the following in consideration of the reported failure mode: the safe and effective use of central venous catheters with power injector pressures (safety cut-off) set above 325 psi has not been established.Do not power inject if maximum injection rate cannot be verified to meet limit of 10 ml/sec.To safely use catheters with a power injector, the technician/healthcare professional must verify prior to use that the maximum safety cut-off pressure limit is set at or below 325 psi and that the maximum flow rate is at or below 10 ml/sec.Power injection procedure: warning: failure to ensure patency of the catheter lumen prior to injection may result in catheter failure.How supplied: 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 could not be established.Appropriate measures have been initiated to address this failure mode.A capa has been opened and is currently in progress to address this failure mode in relation to the suspected product/product family.The appropriate personnel have been notified.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.

Event Description

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

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10869254
• MDR Text Key: 218528977
• Report Number: 1820334-2020-02157
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 12/02/2020; 03/31/2021
• Supplement Dates FDA Received: 12/04/2020; 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention