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

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

Customer (person): postal code: (b)(6).Pma/510(k): unknown as the exact rpn of the complaint device is unknown.(b)(4).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 cook 4 fr single lumen power injectable picc was found to be cracked and leaking following implantation in a pediatric patient.The catheter was removed and replaced once the leak was noticed.Additional information regarding patient and event details has been requested but is not currently available.

Manufacturer Narrative

Investigation ¿ evaluation.It was reported by (b)(6) from (b)(6) hospital that a turbo-ject double lumen over-the wire power injectable picc was removed from a pediatric patient and replaced.No definitive device identification was provided.A review of the complaint history, instructions for use (ifu), and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One unknown picc device was returned for evaluation.A visual examination noted a partial rpn was listed on the return package as: upics-4.0-ct.The clear tubing of the device was also noted to have partially separated from the purple hub.Cook has concluded that the device was manufactured to specification.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the device history record could not be completed as the lot number is unknown.A database search for additional complaints on this device lot could not be carried out; however, the same customer has reported multiple other instances of this failure mode on the same product family.Cook reviewed the lot numbers for those devices and found that no trend in lot number was identified.There is no evidence to suggest there is any nonconforming product in house or out in the field.Additionally, a review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: "warnings: the safe and effective use of turbo-ject picc lines with power injector pressure 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.Precautions: -if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.Catheter maintenance: ¿.If catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with a catheter locking solution.Note: if microclave or other needless 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 concentrations of 10 units/ml to 100 units/ml have been reported adequate to maintain lumen patency.Catheter lock should be reestablished after every use or at least every 24 hours if unused.Before using catheter lumen already locked with heparin, lumen should be flushed twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between administration of different infusates.After use, lumen should be again be flushed with twice the indicated lumen volume using normal saline before reestablishing catheter lock.Strict aseptic technique must be adhered to while using and maintaining catheter.Instructions for use: 10.Secure the catheter to the skin, dress in the standard fashion." based on the information provided, inspection of the returned product, and the results of the investigation, a definitive cause for failure was not established.Appropriate measures have been taken to address this failure mode.A capa is currently open to address this failure mode.The appropriate personnel have been notified.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.

Event Description

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

Event Description

Device return found that the clear tubing has partially separated from the purple hub.

Manufacturer Narrative

D4- rpn: device return revealed a partial rpn of "upics-4.0-ct".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.

• Type of Device: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11087345
• MDR Text Key: 224119025
• Report Number: 1820334-2020-02368
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention