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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon completion of the internal investigation.D.1) turbo-ject double lumen peripherally inserted central venous catheter tray (b)(4).The event is currently under investigation.A follow-up report will be submitted upon completion of the internal investigation.
Event or Problem Description
International customer reported that a peripherally inserted central catheter (picc) was inserted at an unspecified anatomical site.The mandrill guide fractured during removal by the attending physician.The physician removed the catheter and inserted a new picc line.A section of the device did not remain inside the patient¿s body.
Additional Manufacturer Narrative
Investigation - evaluation a review of the drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications and quality control 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.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements, and that the device meets the needs of the user.Review of device history record shows 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, 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 quality engineering 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: 6247689
• Report Number: 1820334-2017-00035
• Device Sequence Number: 19097018
• Product Code: LJS
• UDI-Device Identifier: 00827002491700
• UDI-Public: (01)00827002491700(17)180731(10)6265592
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2017

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: UPICDSY-5.0-CT-OTW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 04/17/2017
• 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: Required Intervention