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

Model Number	N/A
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/31/2017
Type of Reportable Event	Serious Injury
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.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that a patient underwent placement of a turbo-ject over-the-wire single lumen peripherally inserted central venous catheter for an unspecified indication.The customer reported that the catheter split.The event occurred while the patient was at home.The circumstances and handling conditions leading up to the event are not known.The patient returned to the hospital and underwent general anesthesia for removal and replacement of the device.No further event or patient information was provided.The device is not available for evaluation.
Additional Manufacturer Narrative
Additional information: device name turbo-ject over-the-wire single lumen peripherally inserted central venous catheter set.Investigation - evaluation: a review of the complaint history, device history record, instructions for use, specifications and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Review of the 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.Per the instructions for use: ¿extreme caution must be used in placement and monitoring of catheters.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.Notify attending physician immediately.Catheter size should be as small as the use will allow.¿ based on the provided information, no product returned, and the investigation, a definitive root cause cannot be established or reported at this time.Per the health risk assessment no further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: Turbo-Ject
• 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: 6663844
• Report Number: 1820334-2017-01502
• Device Sequence Number: 2059935
• Product Code: LJS
• UDI-Device Identifier: 00827002558847
• UDI-Public: (01)00827002558847(17)190115(10)7533959
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K111244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2017

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UPICS-3.0-CT-OTW-1110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 09/06/2017
• 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
• Patient Age: 2 YR