MAUDE Adverse Event Report: COOK INC COOK SPECTRUM TURBO-JECT; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Brand name: turbo-ject® double lumen minocycline/rifampin over-the-wire power-injectable picc.(b)(6).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that leakage occurred between the catheter and hub of a turbo-ject® double lumen minocycline/rifampin over-the-wire power-injectable picc.Additional information regarding the event and patient details have been requested, but is unavailable at the time of this report.No harm to the patient has been reported.
Additional Manufacturer Narrative
H6 - patient code - no code available (3191): the patient required an additional procedure to preclude permanent impairment or death.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 or Problem Description
In additional information received on 18aug2020, it was reported that the patient required the placement of a new picc line.No additional harm to the patient has been reported.
Additional 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 or Problem Description
A medwatch form was received on 26aug2020.The customer reported they have had issues with leaking and air in the line of double lumen picc lines on three separate occasions.The three events are reported in mdr report numbers: 1820334-2020-01494 (subject of this report), 1820334-2020-01496, and 1820334-2020-01580.The lines for each patient had been in at a minimum of 20 days.There were no documented issues with any of the lines in the 72 hours leading up to the incidents.After identification of the cracked lines, the team was notified.All measures were taken (switching lumens, clamping, parafilm) to protect the patients from infection and air entry.It was reported some of the lines were placed in the groin area for 3 patients, and another involved a patient's right arm.It is unclear at this time which devices and complaints are associated with the groin placement site and which are associated with the right arm placement site.Clarification was received on 16sep2020 that there was no 4th incident.The hubs on some of the leaking lines were white and some were orange.All 3 of the lines had to be replaced, but no additional harm came to any patients.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation: it was reported that leakage occurred when using a turbo-ject double lumen minocycline/rifampin over-the-wire power-injectable picc (upicds-4.0-ct-nt-abrm-1111) from lot 10077046.The line was in the patient for at least 20 days before the leakage was noted.The line was replaced with an unknown device.Cook became aware of this event on 04aug2020 upon being notified by the (b)(6) hospital.The patient reportedly experienced no adverse effects as a result of this incident.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control, as well as a visual inspection and functional test of the returned device were conducted during the investigation.One used double-lumen upic catheter was received.There is biological matter present throughout.Inspection found that the extension tube is split at the orange hub.No damage was noted at the white hub.A leak test was performed on both lumens.Leakage was detected on the orange hub lumen where the extension tube enters the hub.No leakage was noted at the white hub.Cook has concluded that this device was manufactured to specification.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the design history file found that the risks associated with the devices are acceptable when weighed against the benefits.A review of the device history record found no nonconformances or additional complaints associated with the device lot.There is no evidence to suggest there is any nonconforming product in house or out in the field.Additionally, a review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: "intended use: the cook spectrum turbo-ject picc is indicated for multiple injections of contrast media through a power injector.The maximum pressure limit setting for power injectors used with the spectrum turbo-ject picc may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated, as shown on the following table.Warnings: the safe and effective use of spectrum 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: the catheter lumen has ¿ct¿ on the hub to indicate the lumen is power injectable.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." based on the information provided, inspection of the returned product, and the results of the investigation, a definitive cause for failure was not established.Appropriate measures have been initiated to address this failure mode.A capa is currently open to address this failure mode.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.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 or Problem Description
No additional patient/event information has been received since the previous medwatch report was sent.

• Brand Name: COOK SPECTRUM TURBO-JECT
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10408028
• Report Number: 1820334-2020-01494
• Device Sequence Number: 14072574
• Product Code: LJS
• UDI-Device Identifier: 00827002345485
• UDI-Public: (01)00827002345485(17)210722(10)10077046
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K133634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/03/2020

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
• Operator of Device: No Information
• Device Expiration Date: 07/22/2021
• Device Model Number: N/A
• Device Catalogue Number: UPICDS-4.0-CT-NT-ABRM-1111
• Device Lot Number: 10077046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/18/2020; 08/26/2020; 10/14/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 08/27/2020; 09/23/2020; 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 MO
• Patient Weight: 10