MAUDE Adverse Event Report: COOK INC TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
The vascular access insertion nurse has reported that during chemotherapy administration the picc catheter was "fractured" and leaking at the junction between the hubs and the clear flexible tubing.The picc line was replaced with another manufacturers product to continue treatment.The vascular access team reported the staff being unable to safely remove max plus clear needless connectors for the cook picc lines , all other lines within the hospital reportedly work with the same connector or ppv cap no part of the device remained inside the patient.No adverse effect to the patient reported.
Additional Manufacturer Narrative
(b)(4).Product has been received and the investigation is ongoing.A follow up report will be sent upon completion of the investigation.
Event or Problem Description
The vascular access insertion nurse has reported that during chemotherapy administration the picc catheter was "fractured" and leaking at the junction between the hubs and the clear flexible tubing.The picc line was replaced with another manufacturers product to continue treatment.The vascular access team reported the staff being unable to safely remove max plus clear needless connectors for the cook picc lines , all other lines within the hospital reportedly work with the same connector or ppv cap no part of the device remained inside the patient.No adverse effect to the patient reported.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, quality control, trends, and a visual inspection of the device were conducted during the investigation.The visual inspection of the returned device confirmed that the tubing was separated from the purple hub of the device.The attached fitting was easily detached and reattached.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.Per the health risk assessment, no further action is required.

• Brand Name: TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE 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: 5945720
• Report Number: 1820334-2016-00965
• Device Sequence Number: 842497
• Product Code: LJS
• UDI-Device Identifier: 00827002345164
• UDI-Public: (01)00827002345164(17)180226(10)6721089
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K132334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2017

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: UPICDS-4.0-CT-OTW-ST-1111
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/18/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 12/12/2016; 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR