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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Event is currently under investigation.
Event or Problem Description
During the chemotherapy infusion on the (b)(6) year old female patient, the picc line was noted to be leaking from the joint of the external white hub and picc line.The picc line was removed and a new picc line was reinserted for patient and staff safety.No adverse effects to the patient were reported due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, quality control, trends and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the clear tubing was partially separated from the white hub.A leak test was conducted, and a leak was noted to have occurred at the hub.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.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.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.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.Per the health risk assessment, no further action is required.

• Brand Name: TURBO-JECT DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• 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: 5546824
• Report Number: 1820334-2016-00233
• Device Sequence Number: 338158
• Product Code: LJS
• UDI-Device Identifier: 00827002491670
• UDI-Public: (01)00827002491670(17)170220(10)5667900
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K072625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2017

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: UPICDS-5.0-CT-OTW
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/04/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2016
• Supplement Report FDA Received Date: 05/11/2017
• 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: Other
• Patient Age: 64 YR