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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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® double lumen power-injectable picc on an unspecified date.The patient underwent routine treatment including disinfection, blood aspiration, flushing and antibiotic treatment without incident.The patient contacted the staff to report that blood was leaking from the needleless connector following treatment.The nurse reports that the connector was damaged.The connector was removed from the picc line and replaced.It is not known if the connector is the original connector or one that was replaced with a dressing change.No further event details were provided.There are no reported adverse patient consequences related to this event nor any report of a need for medical or surgical intervention to prevent serious injury.The devices is reportedly available for evaluation, however it has not been received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), specifications and visual inspection of the returned device was conducted during the investigation.A visual examination of the returned hub and fitting noted the silicone disc appears slightly concave.An attempt was made to wire the device using a.018¿ wire.The wire would go into the slit but it would not pass all the way through the device.The fitting could not be disassembled from the hub.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.It should be noted there were no other reported complaints for this lot number.Based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Measures have been initiated to address this failure mode.

• Brand Name: TURBO-JECT® DOUBLE LUMEN 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: 6546980
• Report Number: 1820334-2017-00884
• Device Sequence Number: 749646
• Product Code: LJS
• UDI-Device Identifier: 00827002239029
• UDI-Public: (01)00827002239029(17)180407(10)6874451
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K132885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2017

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-NT-1111
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1