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 Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Occupation: senior anaesthetic technician.(b)(4).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 that a cut-like perforation had appeared in the lumen of a turbo-ject® single lumen power-injectable picc.The picc line was initially inserted on (b)(6) 2019 at (b)(6) regional hospital.The patient presented for a dressing change at sjog oncology unit, and the staff noted that the single lumen tube appeared to have a cut-like perforation 0.5 cm from the hub of the lumen.The picc line was then removed and replaced with another device.It is unknown how often the device was accessed.It should be noted the patient was an outpatient.The hospital does not have a picc service, they only insert piccs.No fluids were being delivered through the device at the time, and the device had a needlefree connector attached at the time the perforation was discovered.No other adverse events were reported due to this incident.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Concomitant medical products ¿ product received on: (b)(6) 2019.A review of the complaint history, device history record, documentation, instructions for use (ifu), review of trends, quality control, and specifications of the device, as well as a visual inspection, were conducted during the investigation.The complaint device was returned.After performing a physical investigation of the returned complaint device, visual examination confirmed the extension tube to be partially separated from the purple hub.There were striation marks noted on the extension tube.Additionally, a document based investigation evaluation was performed.It was concluded that the device aspect in question was visually/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 design history record found no related non-conformities for the complaint lot.It should be noted a software search revealed there are two additional complaints from this lot and from the same customer regarding a different failure mode.Based on the information provided, inspection of the returned product and the results of the investigation, a definitive cause could not be established.Appropriate measures are being conducted to address this failure mode.Per the quality engineering risk assessment no further action is required.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.

• 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: 8568835
• Report Number: 1820334-2019-01057
• Device Sequence Number: 2192139
• 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
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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: 71 YR