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Additional information regarding event details was received 23feb2021.A cook spectrum turbo-ject picc was placed on (b)(6) 2021.The picc line was used for infusion of long term vasoactive medications, antibiotics, and intermittent blood product administration, as well as with contrast for a ct on (b)(6) 2021.There were no incidents with placement of the device or sluggish/occluded flow.The picc line was "rewired" without issue on (b)(6) 2021 due to "an infusion port being sheared off when mobilizing" as it got caught between the bedrail and bed.An additional complaint was opened to cover this failure mode and is also reported in this mdr.When the picc line was being removed from the patient, the nurse practitioner noticed a "bulging area" in the line approximately 9cm from the distal tip of the picc.Upon further inspection, a longitudinal slit along the bulge was noted.No other adverse effects were reported to the patient as "medications that would have been infusing would have been a large vein (subclavian)".
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Blank fields on this form indicate the information is unknown, unchanged or unavailable.Correction: h1, h6- annex a.Investigation ¿ evaluation.It was reported that an unknown cook picc device ruptured at the catheter shaft.This rupture was noted when the device was being removed due to an unrelated hub separation, in which the hub sheared off during mobilization of the patient as it got stuck between the bed and the rail.Cook became aware of these events on (b)(6) 2021 and (b)(6) 2021 upon being notified by university of alberta hospital.The patient reportedly experienced no adverse effects as a result of these incidents.A review of the documentation including the complaint history, instructions for use (ifu), quality control, and specifications, as well as a visual inspection and functional test of the returned device, was conducted.A 21.5cm section of catheter tubing was received for evaluation.The hub, extension tubes and manifold were not returned.The extent of the reported hub separation is unclear; it is unknown exactly where on the device the separation occurred.A rupture was found at the midpoint of the tubing section, as the tubing appears to have ballooned and then ruptured.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient controls are in place to detect this failure mode prior to release.A review of the design history file (dhf) found that the risks associated with this device is acceptable when weighed against the benefits.A review of the device history record (dhr) could not be performed, as lot information was unable to be provided by the facility.Cook also reviewed product labeling.The instructions for use (ifu), provides the following information related to the reported failure mode: "intended use ¿the maximum pressure limit setting for power injectors used with the turbo-ject picc may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated, as shown in the following table.(size: 5fr double lumen; maximum flow rate:5ml/sec; injection pressure limit setting: 325 psi).Warnings: ¿ the safe and effective use of turbo-ject picc lines with power injector pressures set above 325 psi has not been established.¿ do not power inject if maximum injection rate cannot be verified to meet limit printed on catheter hub or extension tube.¿ to safely use spectrum turbo-ject picc lines with a power injector, the technician/health care professional must verify prior to use that the maximum pressure limit is set at or below 325 psi and that the maximum flow rate is at or below that which is listed on the catheter.Dynamic and static pressure test results are shown in the following table.How supplied: upon removal from package, inspect the product to ensure no damage has occurred." the information provided upon review of the dmr, ifu, dhr, dhf, and returned device suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a component failure unrelated to manufacturing or design deficiencies contributed to the catheter rupture.It is possible that the power injection of the contrast contributed to ballooning and subsequent rupture of the catheter shaft if excessive pressure was used, or if the catheter lumen was briefly occluded.However, since the customer reported no issues performing the injection, this cannot be confirmed with certainty.A cause for the catheter separation could not be determined.The customer stated that the hub got caught between the bed and the railing.It is feasible to suggest that motion of the patient after this point could result in stress at the hub/tubing junction and eventual separation.Appropriate measures have been taken, as a capa is currently open to investigate the failure mode of picc lines splitting below the hub.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.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.
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