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

Model Number	G34550
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter occupation: pediatric clinical nurse specialist.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 a turbo-ject® double lumen minocycline/rifampin power-injectable picc cracked where the extension tubing meets the hub, resulting in leakage.Eventually, total separation of the junction occurred.The (b)(6)-year old female patient was in the cardiac intensive care unit, was receiving multiple infusions, and was described as "very active".The line was approximately 21 days old when the failure was experienced.As a result, the patient underwent an additional procedure with anesthesia to remove and replace the device.No other adverse effects to the patient have been reported.
Event or Problem Description
In additional information received on (b)(6) 2021, it was reported that power injection was not performed with the device.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation: it was reported that a turbo-ject® double lumen minocycline/rifampin power-injectable picc (upicds-4.0-ct-otw-st-abrm-1111) from lot 13653186 cracked and leaked at the hub.The tubing eventually separated from the hub.The device was removed and replaced with a new line.Cook became aware of this event upon being notified by (b)(6) hospital.No other adverse effects were reported.A review of the complaint history, device history record, instructions for use (ifu), and quality control procedures 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.Review of the device master record (dmr) has shown that sufficient controls are in place to detect this failure mode prior to release.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: intended use the cook spectrum turbo-ject over-the-wire peripherally inserted central venous catheter (picc) sets are indicated for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in ct studies¿ 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 cook 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.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.A review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr of lot 13653186 showed no related nonconformances.Related catheter subassembly lots also showed no related nonconformances.A database search revealed no other complaints from lot 13653186 at the time of investigation.Since there are no related nonconformances or other complaints from this lot, there is no evidence that nonconforming product exists in house or in the field.Based on this and review of the dmr and dhr, cook concludes the device was manufactured to specification.A capa was previously open to address this failure mode.This investigation found that this product issue is related to device design.However, risk assessment determined that the risk is acceptable.The appropriate internal personnel have been notified.Per the 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.

• Brand Name: TURBO-JECT® DOUBLE 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: 11623034
• Report Number: 1820334-2021-01082
• Device Sequence Number: 3919842
• Product Code: LJS
• UDI-Device Identifier: 00827002345508
• UDI-Public: (01)00827002345508(17)221201(10)13653186
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K133634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2022

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: 12/01/2022
• Device Model Number: G34550
• Device Catalogue Number: UPICDS-4.0-CT-OTW-ST-ABRM-1111
• Device Lot Number: 13653186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 06/30/2021; 02/16/2022
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 07/01/2021; 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2021
• 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 Age: 1 YR
• Patient Sex: Female