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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
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.This is one of two medwatch reports being submitted as two separate device events occurred.Reference mdr #'s 1820334-2017-00618 and 1820334-2017-00595 for both reports.The same patient is involved both events.
Event or Problem Description
Customer reported that a turbo-ject® double lumen power-injectable peripherally inserted central catheter (picc) line was implanted on an unspecified date for treatment of leukemia.The hub of the picc line reportedly separated / cracked on or about (b)(6)2017.The patient was returned to the hospital and the device was completely explanted and exchanged with a new device.The conditions and handling circumstances of the device at the time of the event are not known.The device is not available for examination.No further event or patient information was provided.
Additional Manufacturer Narrative
A review of the complaint history, device history record, specifications, instructions for use (ifu) and trends was conducted during the investigation a physical investigation has not been performed as the device was not returned.The turbo-ject® double lumen power-injectable picc is shipped with instructions for use which clearly state the proper warnings, precautions, and instructions for use with each device; specifically; ¿select puncture site and length of catheter needed by assessing patient anatomy and condition.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.The following variables must also be considered in selecting appropriate catheter and length; patient history, patient age and size, access site available, unusual anatomical variables and proposed use and duration of treatment¿.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.Based on the provided information, no product returned, and the investigation, a definitive root cause cannot be established or reported at this time we will notify the appropriate personnel and continue to monitor for similar complaints.Per the health risk assessment no further action is required.

• 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: 6450117
• Report Number: 1820334-2017-00595
• Device Sequence Number: 874408
• Product Code: LJS
• UDI-Device Identifier: 00827002345140
• UDI-Public: (01)00827002345140(17)181109(10)7426624
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2017

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: UPICDS-4.0-CT-NT-1111
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 10/12/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 DA