MAUDE Adverse Event Report: COOK INC SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	G05676
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 spectrum turbo-ject antibiotic power injectable picc line had fractured and began leaking less than sixty days after placement.The patient required a general anesthetic to replace the line.The patient is currently at home on antibiotics.To date, additional information with regards to the patient, device and event are unknown.
Additional Manufacturer Narrative
Blank fields on this form indicate the information has previously been reported, is unknown or is unavailable.Correction investigation - evaluation 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 device was returned with a secur-a-cath and microclave.Visual inspection found the extension tube to be slightly separated from the hub and a kink on the catheter at the distal end of the manifold.The device showed signs of normal use and cracks were not seen.A leak test confirmed the leak at the distal end of the hub where it connects to the extension tube.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 does not show any 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 and failure mode.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, 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 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: SPECTRUM TURBO-JECT ANTIBIOTIC POWER INJECTABLE PICC
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7649665
• Report Number: 1820334-2018-01858
• Device Sequence Number: 11206254
• Product Code: FOZ
• UDI-Device Identifier: 00827002056763
• UDI-Public: (01)00827002056763(17)190621(10)8387346
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2018
• Report Date (Section F): 06/11/2018

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: 06/21/2019
• Device Model Number: G05676
• Device Catalogue Number: UPICS-3.0-CT-NT-ABRM-1110
• Device Lot Number: 8387346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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