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	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2021
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 blood return was unable to be obtained from a turbo-ject® double lumen minocycline/rifampin over-the-wire power-injectable picc.Following noticing that the white lumen of the device was unable to get blood return on (b)(6) 2021, "tpa" was tried.Consequently, the device was removed and replaced on (b)(6) 2021 through the existing access point.The device was used for central venous pressure monitoring and general medications.Another event involving this patient is also reported under patient identifier (b)(6).
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
In additional information received on 21apr2021, it was reported that catheter maintenance protocol included dressing changes every 7 days, cap changes and a heparin lock when not in use.
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.An issue was reported with a turbo-ject® double lumen minocycline/rifampin over-the-wire power-injectable picc (upicds-4.0-ct-nt-abrm-1111) from lot 13755487.The picc was placed on (b)(6) 2021.The lumen with the white hub experienced a lack of blood return on (b)(6) 2021.The device was removed and exchanged on (b)(6) 2021.Cook became aware of this event upon being notified by (b)(6) hospital.The patient reportedly experienced no adverse effects as a result of this incident.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.The device master record (dmr) was reviewed and sufficient controls are in place to detect this failure mode prior to release.The product¿s design history file (dhf) has controls in place to address the failure.A review of the device history record (dhr) showed no nonconformances.A database search revealed one other complaint for the same failure mode under this lot number at the time of this investigation.Additional potentially related lots were reviewed and no additional complaints were noted from these lots.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: warnings: catheter tip position should be verified by x-ray and monitored on a routine basis.Periodic lateral view x-ray is suggested to assess tip location in relation to vessel wall.Tip position should appear to be parallel to vessel wall.Precautions: if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.Catheter maintenance: catheter entry site must be prepared and maintained in a manner consistent with standard procedure for central venous catheterization.After catheter placement and prior to use, tip position and lumen patency should be confirmed by free aspiration of venous blood.If blood is not freely aspirated, catheter tip position should be immediately reevaluated by physician.If catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with heparinized saline solution.Note: if microclave or other needleless adapters approved for saline only lock are used, saline only catheter lock may be used.Catheter heparinization should be determined by institutional protocol and clinical judgement.Heparin lock should be reestablished after every use, every 24 hours, or in accordance with the approved facility protocol if catheter is unused.Before using catheter lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between administration of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin lock.The information provided upon review of the dmr, ifu, dhr, and dhf suggests that the device was manufactured to specification, and that there are no nonconforming devices in house or out in the field.There are many potential factors that may have contributed to the device failure including placement site of the device and general activity.The distal tip of the catheter may have migrated during its indwelling, potentially to a vessel wall which would have blocked blood return.General activity by the patient and/or attending employees may have also contributed displacement of the device.However, neither of these possible causes can be confirmed without additional information.Based on the information provided and the results of the investigation, it was concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.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: 11680903
• Report Number: 1820334-2021-01148
• Device Sequence Number: 14227945
• Product Code: LJS
• UDI-Device Identifier: 00827002345485
• UDI-Public: (01)00827002345485(17)221228(10)13755487
• 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,company representati
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2022

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: 12/28/2022
• Device Model Number: N/A
• Device Catalogue Number: UPICDS-4.0-CT-NT-ABRM-1111
• Device Lot Number: 13755487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 04/21/2021; 02/21/2022
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 04/22/2021; 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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: 12 YR
• Patient Sex: Male
• Patient Weight: 100 KG