MAUDE Adverse Event Report: COOK INC TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Occupation: senior anaesthetic technician.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 a 100ml infusion was given to the patient, followed by a 30ml flush.When the flush began, it was noted that fluid started to leak out of the infusion site.The picc line was then removed, and a "small tear was found 5-6cm in the line under the skin." the leak could be described as "dripping" when a manual flush was pushed through the line once removed from the patient's skin.The device will not be returned for investigation, as it was discarded by the facility.Additional questions regarding event details and patient outcome have been requested, but have not been made available at the time of this report.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation - evaluation a review of documentation including the complaint history, device history record, instructions for use, quality control, specifications and trends of the device was conducted during the investigation.The complaint device was not returned; therefore, a physical examination of the device not conducted.However, a document-based investigation evaluation was performed.It was concluded that the device aspect in question was visually and functionally inspected by quality control and no related gaps in production or processing controls were noted.The risk specification for this product includes the loss of use failure mode and identifies the risk controls that are in place to mitigate the risk of this type of failure.A review of the device history record showed no relevant nonconformances in lot 9033234 that could have contributed to the failure of the device.It should be noted that there were two other complaints from the same customer reported for this lot, in which one was related to the reported failure mode.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: intended use the maximum pressure limit setting for power injectors used with the turbo-ject picc may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.Warnings the safe and effective use of 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 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 low rate is at or below that which is listed on the catheter.Precautions if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.How supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cook place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment no further action is required.The appropriate personnel have been notified and we 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: TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8639682
• Report Number: 1820334-2019-01243
• Device Sequence Number: 1831322
• Product Code: LJS
• UDI-Device Identifier: 00827002345195
• UDI-Public: (01)00827002345195(17)200719(10)9033234
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/19/2020
• Device Model Number: N/A
• Device Catalogue Number: UPICS-4.0-CT-NT-1111
• Device Lot Number: 9033234
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1