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

Catalog Number UPICS-4.0-CT-OTW-ST-ABRM-1111

Device Problems Fracture (1260); Material Separation (1562); Fitting Problem (2183)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  Injury  

Manufacturer Narrative

Device name: turbo-ject® single lumen minocycline/rifampin over-the-wire power-injectable picc.Product lot # was reported as 3213588, which does not match the reported device information.Clarification has been requested.Occupation: ir attending.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that a turbo-ject single lumen minocycline/rifampin over-the-wire power-injectable picc broke where the extension tubing and hub connect.Additional information regarding the patient, device, and event has been requested but is currently unavailable.

Event Description

It was reported that no procedures were being performed via the device.The patient required removal and replacement of the picc line due to the catheter breakage.In regards to patient hospitalization/prolonged hospitalization, it was noted that there was a delay due to the new line being placed.No power injection was being used.

Manufacturer Narrative

G6- report type (mw): 15-day was inadvertently not selected in the initial report.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 Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Correction: d9 - product received on.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 Description

No additional information has been received since the last report was submitted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: it was reported that a turbo-ject single lumen minocycline/rifampin over-the-wire power-injectable picc broke where the extension tubing and hub connect.No procedures were being performed via the device.The patient required removal and replacement of the picc line due to the catheter breakage.In regard to patient hospitalization/prolonged hospitalization, it was noted that there was a delay due to the new line being placed.No power injection was being used.Investigation evaluation: a review of the complaint history, device history record, instructions for use (ifu), and quality control procedures was conducted during the investigation.A visual inspection and functional test of the complaint device was also conducted.One single-lumen upic was received in a used condition.There is a hole in the extension tubing at the hub joint.A leak test was performed, confirming a leak at this hole.A document-based investigation evaluation was performed.Although lot information is unknown, three possible lots were identified during a search of sales records.A review of the potential lots and related subassembly lots found no related nonconformances.A database search revealed no other complaints on the possible lots.The information provided upon review of the dmr, ifu, dhr, dhf, and investigation of the returned device suggests that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in-house or in the field.The product ifu states that the device is 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 ifu instructs to inspect the product upon removal from the package, to ensure no damage has occurred.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook was unable to make a definitive conclusion for the cause of this event.There is currently a capa investigation open to investigate this product failure mode.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.

• Type of Device: 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: 11455523
• MDR Text Key: 244409476
• Report Number: 1820334-2021-00916
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K133634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/28/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UPICS-4.0-CT-OTW-ST-ABRM-1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 03/29/2021; 08/16/2021; 01/24/2022
• Supplement Dates FDA Received: 04/12/2021; 08/23/2021; 01/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 144 KG