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

Catalog Number UNKNOWN

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

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 an unknown cook 4 fr single lumen picc device was leaking due to a crack following implantation in a pediatric patient.As a result, the femoral-placed device had to be removed and replaced.Additional information has been requested, but the customer has indicated that no further information regarding this event is available.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Investigation ¿ evaluation.It was reported by courtenay wager from the university of alberta hospital that a 4 french single lumen picc (peripherally inserted central-venous catheter) was removed from a pediatric patient due to cracking/leaking.The device was placed in a pediatric patient and had to be removed for the second time.The customer indicated that many of the events reported are femoral placed that require replacement.No patient information was provided.No information was provided accessory devices attached to the device, mediations being infused, patient activity level, or patient environment.A review of the complaint history, instructions for use (ifu), and quality control of the device was conducted during the investigation.The complaint device was not returned for evaluation.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 instance 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.

• Brand Name: UNKNOWN
• 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: 11088785
• MDR Text Key: 224146208
• Report Number: 1820334-2020-02371
• 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: company representative,foreig
• Type of Report: Initial,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
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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