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

Catalog Number	UPICDS-4.0-CT-NT-1111
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient code: no code available ((b)(4)) the picc line had to be replaced.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 the the hub broke where the catheter and white hub meet on a 4fr turbo-ject® double lumen power-injectable picc (peripherally inserted central catheter) requiring another picc line to be placed.No additional consequences to the patient have been reported.Additional information regarding the event has been requested but was not available at this time of this report.
Additional Manufacturer Narrative
Correction on (b)(6) 2018, an initial report was submitted stating g4 as 26jun2018.The correct date is (b)(6) 2018.Additional information: information was received from the customer on (b)(6) 2018.The device "broke where the tubing and white hub meet".This device malfunction was found after placement during the maintenance phase and it was immediately clamped and replaced.A new line was placed successfully.Investigation-evaluation a review of the complaint history, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The device returned was visually inspected and the white hub was verified to be separated from the tubing.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows zero nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the information provided and the results of our investigation, a definitive root cause cannot be determined at this time, however appropriate measures have been initiated to address this failure mode.Per the [quality engineering] risk assessment, monitoring will continue to be performed 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.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 or Problem Description
A sus voluntary report, mw5080167, was received on (b)(6) 2018 and reconciled with this case.The final report submitted on (b)(6) 2018 remains unchanged.

• Brand Name: TURBO-JECT® DOUBLE 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: 7680498
• Report Number: 1820334-2018-02096
• Device Sequence Number: 1384238
• Product Code: LJS
• UDI-Device Identifier: 00827002345140
• UDI-Public: (01)00827002345140(17)200211(10)8577887
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K132334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2020
• Device Catalogue Number: UPICDS-4.0-CT-NT-1111
• Device Lot Number: 8577887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 08/02/2018; 10/25/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/28/2018; 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention