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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device name: turbo-ject over-the-wire single lumen peripherally inserted central venous catheter set.This investigation is currently under investigation.A follow-up report will be generated upon the conclusion of the investigation.
Event or Problem Description
Customer reported to the (b)(6) therapeutic goods administration regulatory agency and subsequently to the manufacturer ¿that the device had snapped between the catheter and purple bung attachment end of line".The peripherally inserted central catheter (picc) line was previously implanted on an unspecified date.The patient ¿required a reinsertion of picc during a planned procedure (reversal of stoma).¿ a section of the device did not remain inside the patient¿s body.No further patient or event details were provided.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), and specifications 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.Review of device history record shows no nonconforming events which could contribute to this failure mode.The device is shipped with an instruction for use (ifu) that describes the intended use; specific items are addressed such as: 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.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 health risk assessment no further action is required.

• 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: 6264409
• Report Number: 1820334-2017-00108
• Device Sequence Number: 10785366
• Product Code: LJS
• UDI-Device Identifier: 00827002558847
• UDI-Public: (01)00827002558847(17)180906(10)7217618
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2017

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: UPICS-3.0-CT-OTW-1110
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/19/2017
• Supplement Report FDA Received Date: 06/12/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Weight: 47