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

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
The picc line was placed in the patient on (b)(6) 2016.The patient became inpatient on (b)(6) 2016 and the picc line was noted to be functioning.On (b)(6) 2016, it was noted that the purple line had a crack and was clamped off.Patient had slipped the day prior and the iv tubing going into the picc was tugged.Both lumens were checked and functioning.The picc line was replaced.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
(b)(4).(additional information provided/updated): investigation/evaluation 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.During the course of the investigation, a review of the complaint history, device history record, and specifications of the product was conducted.Per specification, there is a confirmation that the correct manifold has been used and its security is verified.There is also an inspection, verifying the product is free of any visible cuts, holes or foreign matter (dirt, hair, paper, fuzz, etc.).Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Measures have been initiated to address this nonconformance.We will continue to monitor for similar complaints and have notified the appropriate internal personnel.
Event or Problem Description
The picc line was placed in the patient on (b)(6) 2016.The patient became inpatient on (b)(6) 2016 and the picc line was noted to be functioning.On (b)(6) 2016 it was noted that the purple line had a crack and was clamped off.Patient had slipped the day prior and the iv tubing going into the picc was tugged.Both lumens were checked and functioning.The picc line was replaced.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

• Brand Name: TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE 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: 5784989
• Report Number: 1820334-2016-00621
• Device Sequence Number: 692264
• Product Code: LJS
• UDI-Device Identifier: 00827002345164
• UDI-Public: (01)00827002345164(17)180115(10)6474396
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2016

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: UPICDS-4.0-CT-OTW-ST-1111
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2016
• Supplement Report FDA Received Date: 10/24/2016
• 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: Other