MAUDE Adverse Event Report: COOK INC TURBO-JECT® DOUBLE LUMEN BEDSIDE 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 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.
Event or Problem Description
Customer reported that a turbo-ject® double lumen bedside power-injectable picc was implanted on (b)(6) 2017 for an unspecified indication.The catheter reportedly leaked at the junction of the catheter and the hub.The conditions and handling circumstances leading to the event are not known.The device was completely explanted and a replacement catheter placed on (b)(6) 2017.No further information was provided.The device was returned for evaluation.
Additional Manufacturer Narrative
A review of the complaint history, instructions for use, device history record, specifications, and quality control data was conducted during the investigation.Visual inspection of the returned device was performed and noted that the tubing was partially separated from the purple hub.The turbo-ject® double lumen bedside power-injectable picc 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." 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 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.A complaint history search revealed this record to be the only reported complaint associated with the complaint lot number.Based on the provided information, inspection of returned product, 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.Measures have been previously initiated to address this issue.

• Brand Name: TURBO-JECT® DOUBLE LUMEN BEDSIDE 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: 6484966
• Report Number: 1820334-2017-00652
• Device Sequence Number: 13752664
• Product Code: LJS
• UDI-Device Identifier: 00827002345119
• UDI-Public: (01)00827002345119(17)190110(10)7577031
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2017

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-40NT-1111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: 09/29/2017
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1