MAUDE Adverse Event Report: COOK INC TURBO-JECT® SINGLE LUMEN MINOCYCLINE/RIFAMPIN POWER-INJECTABLE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	G34553
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter occupation: manager.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 the extension tubing of a turbo-ject® single lumen minocycline/rifampin power-injectable picc partially disconnected from the distal hub.While the device did not completely separate, it was reported to have "almost completely disconnected".Consequently, the device was removed and replaced with a like device.No other adverse effects to the patient have been reported.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: it was reported that the extension tubing of a turbo-ject® single lumen minocycline/rifampin power-injectable picc partially disconnected from the distal hub.While the device did not completely separate, it was reported to have "almost completely disconnected".Consequently, the device was removed and replaced with a like device.No other adverse effects to the patient have been reported.Investigation evaluation: reviews of quality control procedures, instructions for use, complaint history, and the device history record were conducted during the investigation.The complaint device was not returned to cook for investigation; therefore, a device failure analysis could not be performed.A photo was provided, however, showing the extension tube partially separated from the hub.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu cautions ¿if lumen flow is impeded, do not force injection or withdrawal of fluids.¿ the ifu also warns ¿do not power inject if maximum injection rate cannot be verified to meet limit printed on catheter hub or extension tube¿.The ifu also instructs to inspect the product for damage upon removal from the package.The information provided upon review of the device master record, ifu and design history file suggests that the device was manufactured to specification.There is no evidence of nonconforming product in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.There is no indication the device was manufactured out of specification.A previously completed capa found that this issue is related to device design.However, risk assessment determined that the risk is acceptable.Based on the information provided and the results of the investigation, cook has concluded that device design contributed to this event.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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 information has been received since the last report was sent.

• Brand Name: TURBO-JECT® SINGLE LUMEN MINOCYCLINE/RIFAMPIN POWER-INJECTABLE PICC
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 11685413
• Report Number: 1820334-2021-01156
• Device Sequence Number: 19604339
• Product Code: LJS
• UDI-Device Identifier: 00827002345539
• UDI-Public: (01)00827002345539(17)220721(10)13477518
• Combination Product (Y/N): Y
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K133634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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: Health Professional
• Device Expiration Date: 07/21/2022
• Device Model Number: G34553
• Device Catalogue Number: UPICS-4.0-CT-NT-ABRM-1111
• Device Lot Number: 13477518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown