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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Investigation evaluation: a review of documentation including the device history record, complaint history, instructions for use (ifu), quality control and trends of the device 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.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 found no relevant nonconformances that could have contributed to the failure mode.It should be noted that there were no other complaints reported for lot 9477001.There is no evidence to suggest that nonconforming product exists in house or in field.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, as shown on the following table.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 prior to use that the maximum pressure limit is set at or below that which is listed on the catheter.Dynamic and static pressure test results are shown in the following table.Precautions: if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.How supplied: 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.Appropriate measures are being conducted to address this failure mode.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.
Event or Problem Description
It was reported that a turbo-ject power injectable device was being used on a (b)(6) patient when the "fitting between the tubing of the picc line and the tubing carrying the perfusion bags" broke after 38 days of use.It was also reported that there was no difficulty during placement of the device.This occurred after the patient had been released from hospital care.This device had been inserted in place of a different device following the occurrence of the same failure mode (captured in an additional report with patient identifier: (b)(6), mfg report reference #: (b)(4)).Ultimately, the device was removed at the hospital and not replaced.As reported, the patient did not experience any adverse effects due to this occurrence.The device will not be returned to the manufacturer, as it was not retained by the facility.

• Brand Name: TURBO-JECT POWER INJECTABLE
• 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: 9071704
• Report Number: 1820334-2019-02336
• Device Sequence Number: 19729882
• Product Code: LJS
• UDI-Device Identifier: 00827002561960
• UDI-Public: (01)00827002561960(17)210125(10)9477001
• Combination Product (Y/N): N
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

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: 01/25/2021
• Device Model Number: N/A
• Device Catalogue Number: UPICS-5.0-CT-OTW-ST-1110
• Device Lot Number: 9477001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR