|
Model Number N/A |
Device Problems
Crack (1135); Fluid/Blood Leak (1250); Fitting Problem (2183)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/11/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.D1 - device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set e3 - occupation: clinical nurse manager.H6 - annex g: g0402301 - catheter hub.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 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 or that a death or serious injury occurred; nor is it admission 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
|
It was reported that the medial hub of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter that placed in a female patient leaked while flushing.The device was placed on an unknown date in the left atrium for blood monitoring and medication administration.The patient was not mobile and was on a ventilator.No fitting was connected to the device at the time of failure.During flushing, leaking was discovered in the medial (blue) hub.The line was clamped after the discovery.The device was removed and replaced.The device was returned to the manufacturer on 06nov2023.During the preliminary device failure analysis, the device was noted to be leaking from the blue hub.A possible crack was noted on the blue port as well.
|
|
Manufacturer Narrative
|
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
|
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
|
|
Event Description
|
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
|
|
Manufacturer Narrative
|
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 - annex a investigation ¿ evaluation on (b)(6) 2023, cook was informed of an event on (b)(6) 2023.It was reported that the hub of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter leaked while flushing.The device was placed on (b)(6) 2023 in the left atrium for blood monitoring and medication administration.The patient was not mobile and was on a ventilator.No fitting was connected to the device at the time of failure.During flushing, leaking was discovered at the blue hub and removed on (b)(6) 2023.Reviews of documentation including the complaint history, quality control procedures, and instructions for use (ifu), as well as a visual inspection and functional test of the returned device, were conducted during the investigation.One used device was returned to cook for evaluation.Table top testing found leakage at the blue hub.Upon visual inspection, the blue hub was noted to be cracked.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.An expanded sales search to the customer was unable to identify the complaint lot.Based on this information, the device was manufactured to specification.There is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The product ifu, [c_t_ctulmabrm_rev7] ¿cook spectrum central venous catheter minocycline/rifampin antibiotic impregnated power injectable,¿ provides the following information to the user related to the reported failure mode: warnings ¿the safe and effective use or central venous catheters with power injector pressures (safety but-off) set above 325 psi has not been established.Do not power inject if maximum injection rate cannot be verified to meet limit of 10ml/sec.To safely use catheters with a power injector, the technician/heath care 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.Do not exceed the maximum flow rate of 10 ml/sec.Exceeding the maximum flow rate of 10 ml/sec may result in catheter failure and/or catheter tip displacement.Power injector machine pressure limiting (safety cut-off) settings may not prevent over-pressurization of an occluded catheter.Precautions ¿catheter should not be used for long-term indwelling applications.¿ based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded that the main cause of failure was design-related.A capa was previously opened, and a project is currently open to further investigate this failure mode.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.Appropriate measures have been taken to address this failure mode.A project is in place to further investigate this failure mode.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.
|
|
Manufacturer Narrative
|
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 - annex g, annex d, investigation conclusion (see below) based on the information provided, inspection of the returned device, and the results of the investigation, cook determined, among other variables, that over-engagement of external components onto the hub may contribute to cvc hub cracking.The use of hemostats or lubrication, such as fluids remaining on the hub, during application of external components may further contribute to over-engagement, introducing additional forces to the hub.The investigation concluded that the main cause of failure was a component failure without a design or manufacturing deficiency.The reported failure is captured in the risk documentation and is occurring within the acceptable range.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.Appropriate measures have been taken to address this failure mode.A capa was previously opened to further investigate this failure mode.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.
|
|
Search Alerts/Recalls
|
|
|