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 Known Impact Or Consequence To Patient (2692)
Date of Event	11/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: smartsite needle free valve.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 seven (7) days after a turbo-ject® double lumen power-injectable picc line was placed, the white hub was found cracked where the hub and catheter meet.A smartsite needle free valve was connected to the lumen and no instrument was used to tighten/release the fitting.70% alcohol swab was used to scrub the hub and allowed to dry completely before a new needless connector placed.The line was clamped and another lumen was used as intended.As reported, the device was found cracked while the patient was receiving the last round of chemotherapy, therefore, the device was not replaced.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Device evaluation: one used product was returned for investigation.Visual exam notes the clear tubing is partially separated from the white hub.Investigation: a document-based investigation reviewed the following: instructions for use, quality control specifications, complaint history and device history records.There is no evidence to suggest that product was not manufactured to current specifications.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.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 2 other reported complaints for this lot number for fitting, cracked and fitting, damaged.Risk assessment determined that risk controls are in place to mitigate this failure mode.The appropriate personnel were notified, and we will continue to monitor for similar complaints.Appropriate measures have been initiated to investigate this failure mode.Conclusion: based on the information provided, examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.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.

• 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: 8131186
• Report Number: 1820334-2018-03461
• Device Sequence Number: 1770889
• Product Code: LJS
• UDI-Device Identifier: 00827002345140
• UDI-Public: (01)00827002345140(17)200622(10)8972600
• 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
• Report Date (Section B): 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/22/2020
• Device Catalogue Number: UPICDS-4.0-CT-NT-1111
• Device Lot Number: 8972600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 12/19/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1