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

Model Number	G23903
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a turbo-ject® double lumen over-the-wire power-injectable picc was leaking at the purple hub due to a crack.To date, additional information regarding the patient and event have not been made available.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.This medwatch report is associated with medwatch 1820334-2018-01381 as two device issues occurred with the same patient.
Additional Manufacturer Narrative
Additional information was received (04jun2018) which identified that this incident took place with two separate patients and not one patient as noted in the initial report.It was also reported, no further information is available.Device available for eval: yes; product received on: 06/13/2018.Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), quality control and visual inspection/dimensional verification of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that there is a separation around 3/4 of the extension tubing at the joint with the purple hub.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.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 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.Ifu states: precautions - if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.How supplied - store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.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.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.

• 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: 7489864
• Report Number: 1820334-2018-01382
• Device Sequence Number: 334162
• Product Code: LJS
• UDI-Device Identifier: 00827002239036
• UDI-Public: (01)00827002239036(17)191016(10)8297197
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K132885
• 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): 07/16/2018

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: G23903
• Device Catalogue Number: UPICDS-5.0-CT-40NT-1111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1