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	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Patient code: no code available - additional procedure required 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 was placed on (b)(6) 2018 and found cracked where the hub and catheter meet on the purple lumen on (b)(6) 2018.A smartsite needle free valve was attached to the catheter and nothing was used to tighten or release the fitting.An additional procedure was required to remove and replace the device.As reported, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
A sus voluntary report, mw5080167, was received on 25oct2018 and reconciled with this case.
Additional Manufacturer Narrative
Device evaluation: the reported used device was returned to cook inc.For evaluation.Visual examination verified the hub was cracked.Investigation: a document-based investigation reviewed the following: instructions for use, quality control specifications, manufacturing instructions, complaint history and the device history record.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 related nonconforming events that could contribute to this failure mode.A complaint history search revealed two additional similar complaints have been reported against this lot.A review of relevant manufacturing documents was conducted.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.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.Conclusion 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 investigate this failure mode.

• 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: 7944628
• Report Number: 1820334-2018-03057
• Device Sequence Number: 16479688
• Product Code: LJS
• UDI-Device Identifier: 00827002345140
• UDI-Public: (01)00827002345140(17)200531(10)8922063
• 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): 12/13/2018
• 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: 05/31/2020
• Device Catalogue Number: UPICDS-4.0-CT-NT-1111
• Device Lot Number: 8922063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 10/25/2018; 11/16/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 11/21/2018; 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 09/25/2018