MAUDE Adverse Event Report: COOK INC TURBO-JECT; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device brand name: turbo-ject over-the-wire single lumen peripherally inserted central venous catheter set.(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The international customer reported that the picc line broke at the junction between the catheter and the hub, which necessitated an additional procedure.The details regarding the additional procedure were not supplied.No further complications were reported.
Additional Manufacturer Narrative
Investigation - evaluation: a review of device history record, documentation, specifications, complaint history, instructions for use (ifu) and visual inspection was conducted during on the returned product during the investigation.The complaint device was returned for investigation and analysis; a visual examination noted the clear tubing is partially separated from the purple hub.The turbo-ject over-the-wire single lumen peripherally inserted central venous catheter is shipped with instructions for use which clearly state the proper warnings, precautions, and instructions for use with each device.Specifically; ¿extreme caution must be used in placement and monitoring of catheters.Do not power inject if maximum injection rate cannot be verified to meet limit printed on catheter hub or extension tube.If lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.Catheter size should be as small as the use will allow.Failure to ensure patency of the catheter lumen prior to injection may result in catheter failure¿.A thorough review of the device history record did not observe any non-conformances that may have contributed to this incident associated with the complaint lot number.Also, a complaint history search for similar complaints revealed this to be the only reported complaint associated with the complaint lot number.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A definitive root cause could not be determined, however; based on the provided information and evaluation of the returned device, the actual root cause is deemed to be; ¿inconclusive¿.We will notify the appropriate personnel and continue to monitor for similar complaints.Measures have been previously initiated to address this issue.

• Brand Name: TURBO-JECT
• 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: 6824596
• Report Number: 1820334-2017-02542
• Device Sequence Number: 1408068
• Product Code: LJS
• UDI-Device Identifier: 00827002558847
• UDI-Public: (01)00827002558847(17)180525(10)6916891
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICS-3.0-CT-OTW-1110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 10/31/2017
• 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