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 Codes	Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device name: turbo-ject® double lumen minocycline/rifampin over-the-wire power-injectable picc.Reporter occupation: ir lead tech.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 orange lumen of a turbo-ject® double lumen minocycline/rifampin over-the-wire power-injectable picc began leaking blood from the distal portion of the line.The device was placed on (b)(6) 2021 and was used for medication injection.The line was locked with heparin when not in use.The leaking catheter was removed and replaced on (b)(6) 2021.Additional information regarding event and patient details has been requested, but is currently unavailable.
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
In additional information received on 14jul2021, it was reported that the device failure was noticed on (b)(6) 2021, almost one month after initial placement on (b)(6) 2021.It was confirmed that the patient required a line exchange under general anesthesia.Bedside infusions were being administered, with no power injection used.The line was secured to the patient with sutures and tegaderm.The complaint device is being held by the hospital and available to observe at the facility.
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.(b)(6) hospital in the united states informed cook of an incident involving a upicds-4.0-ct-nt-abrm-1111 (turbo-ject® double lumen minocycline/rifampin over-the-wire power-injectable picc) from lot 13678806.It was reported that blood was leaking from the distal part of the picc line, and needed to be exchanged.No adverse effects were reported to the patient due to this occurrence.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control procedures were 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.The device master record (dmr) was reviewed and device drawings, manufacturing instructions, quality control procedures, and specifications were identified.Sufficient controls are in place to detect this failure mode prior to release.The product¿s design history file (dhf) was reviewed and the risks associated with this device were acceptable when weighed against the benefits.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 for the complaint lot did not have related nonconformances.There are additional complaints on lot 13678806, however there is currently a capa to investigate this failure mode.All of the additional complaints are from the same user facility for the same reported failure.While there are additional complaints on this lot, there is currently no evidence of manufacturing deficiency.There is no evidence of nonconforming devices in house or in the field.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 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.There is no indication the device was manufactured out of specification.This product failure was previously investigated under a capa.The capa investigation found that the root cause is related to inadequate flexural strength in a previous hub design change.Investigation further found that the devices were manufactured to specification and there was no evidence of lot-related issues.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: 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
• 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: 12180360
• Report Number: 1820334-2021-01826
• Device Sequence Number: 3298733
• Product Code: LJS
• UDI-Device Identifier: 00827002345485
• UDI-Public: (01)00827002345485(17)221201(10)13678806
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2022

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: N/A
• Device Catalogue Number: UPICDS-4.0-CT-NT-ABRM-1111
• Device Lot Number: 13678806
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 07/14/2021; 04/26/2022
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 07/20/2021; 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2021
• 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: 4 YR
• Patient Sex: Female