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	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: bd carefusion smartsite needlefree valve 2000e.The patient required an additional procedure to replace the device.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 turbo-ject® double lumen power-injectable picc broke where the white hub and catheter meet.This catheter was placed on (b)(6) 2018 and remained in situ and clamped until it was replaced on (b)(6) 2018.The user facility reported this event on a 3500a form on (b)(6) 2018.The reported complaint device was the replacement catheter used after the initial device presented a similar failure reported on medwatch 1820334-2018-02595.As reported, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Investigation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.The complaint device was not returned; therefore, no physical examination could be performed.However, a document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.A review of the device history record of the finished product shows no 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.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.Monitoring will continue to be performed for similar complaints.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
An sus voluntary report, mw5080167, was received on 25oct2018 and reconciled with this case.

• 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: 7881565
• Report Number: 1820334-2018-02631
• Device Sequence Number: 2508404
• Product Code: LJS
• UDI-Device Identifier: 00827002345140
• UDI-Public: (01)00827002345140(17)200504(10)8863294
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018
• Report Date (Section F): 09/25/2018

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: 05/04/2020
• Device Catalogue Number: UPICDS-4.0-CT-NT-1111
• Device Lot Number: 8863294
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 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
• Patient Age: 3 YR
• Patient Weight: 13
• Date Report Sent to FDA: 09/25/2018