MAUDE Adverse Event Report: COOK INC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Turbo-ject over-the-wire single lumen peripherally inserted central venous catheter set.(b)(4).The event is currently under investigation.
Event or Problem Description
The (b)(6) male patient had a picc line inserted in the right basilica vein for 27 days to administer iv therapy.It was reported that the line fractured and began leaking at the junction between the hub and the clear flexible tubing.The doctor reported there have been no changes in clinical practice with regards to care, maintenance or insertion of the device.Reportedly the patient did require additional general anesthesia for another picc line insertion on (b)(6) 2016 procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Brand name: turbo-ject over-the-wire single lumen peripherally inserted central venous catheter set (b)(4).The event is currently under investigation.
Event or Problem Description
The (b)(6) old male patient had a picc line inserted in the right basilica vein for 27 days to administer iv therapy.It was reported that the line fractured and began leaking at the junction between the hub and the clear flexible tubing.The doctor reported there have been no changes in clinical practice with regards to care, maintenance or insertion of the device.Reportedly the patient did require additional general anesthesia for another picc line insertion on (b)(6) 2016 procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Brand name: turbo-ject over-the-wire single lumen peripherally inserted central venous catheter set.(b)(4).A review of the review of complaint history, review of device history record, specifications and trends of the device was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The device history record was reviewed and no non-conformances were noted.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the risk assessment no further action is required.
Event or Problem Description
The (b)(6) male patient had a picc line inserted in the right basilica vein for 27 days to administer iv therapy.It was reported that the line fractured and began leaking at the junction between the hub and the clear flexible tubing.The doctor reported there have been no changes in clinical practice with regards to care, maintenance or insertion of the device.Reportedly the patient did require additional general anesthesia for another picc line insertion on (b)(6) 2016 procedures due to this occurrence.

• 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: 6002674
• Report Number: 1820334-2016-01131
• Device Sequence Number: 671282
• Product Code: LJS
• UDI-Device Identifier: 00827002558847
• UDI-Public: (01)00827002558847(17)171019(10)6273415
• Combination Product (Y/N): N
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UPICS-3.0-CT-OTW-1110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/07/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/06/2016
• Supplement Report FDA Received Date: 10/07/2016; 10/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 MO
• Patient Weight: 7