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	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
International customer reported that a turbo-ject® single lumen power-injectable picc was implanted for treatment of a pre-existing (b)(6) infection with resultant fever.The device recipient is a post-acute care and rehabilitation patient.A leak was identified at the valve level (purple colour) at an unspecified time following implantation.The leak was observed while attempting to administer any liquid.The device was explanted; it is not known if the explant was at the end of device use.The patient did not require any additional procedures.No further event or patient information was provided.Follow-up to the customer was conducted requesting the date of device implant and if the patient was culture positive for the reported s.Epidermitis infection prior to the implant.The patient was treated with vancomycin for 10 days with the same picc line.The customer responded indicating no one is able to provide any information.The device was received by the manufacturer for evaluation.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, drawing, instructions for use,specifications as well as a visual inspection of the actual device was completed during this investigation.One opened complaint device was returned for investigation; a functional test was performed by applying a hemostat and inserting water using a syringe.A leak was noted at the hub.A visual examination noted the purple hub has multiple cracks.The turbo-ject® single lumen power-injectable picc is shipped with instructions for use which clearly states the proper warnings, precautions, and instructions for use.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.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¿.Measures have been previously initiated to address this issue.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6614771
• Report Number: 1820334-2017-01273
• Device Sequence Number: 18998506
• Product Code: LJS
• UDI-Device Identifier: 00827002238978
• UDI-Public: (01)00827002238978(17)181014(10)7359253
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICS-5.0-CT-NT-1111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 09/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1