MAUDE Adverse Event Report: COOK INC TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2017
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 patient had a turbo-ject standard power injectable picc line implanted on an unspecified date.The picc line broke at the junction of the catheter and the base.It is opined that the device was explanted, however no further event information was provided.A section of the device did not remain inside the patient¿s body.The device is available for evaluation however it has not been received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, instructions for use, specifications and visual examination of the returned device was conducted during the investigation.The device was returned for evaluation and visual inspection revealed that the clear tubing was completely separated from the purple hub.It was determined that the failure originated at the molded transition between the silicone extension tubing and the over-molded plastic hub.A document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The turbo-ject standard power injectable picc line picc is shipped with instructions for use that clearly states the proper warnings, precautions and instructions for use.Based on the provided information and evaluation of the returned device, a definitive root cause cannot be established or reported at this time.Measures have been initiated to address this issue.

• Brand Name: TURBO-JECT STANDARD POWER INJECTABLE PICC LINE 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: 6537060
• Report Number: 1820334-2017-00879
• Device Sequence Number: 16551006
• Product Code: LJS
• UDI-Device Identifier: 00827002037779
• UDI-Public: (01)00827002037779(17)181006(10)7338643
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2017

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-4.0-CT-NT-1110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 07/25/2017
• Patient Sequence Number: 1