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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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
Customer reported that the turbo-ject® double lumen bedside power-injectable picc catheter broke above both the purple and white hub where the clear part of the tubing is connected.The hubs did not break off completely.The device was reportedly "in the patient for some time." the catheter was removed.It is not known if the device was replaced or removed as the end of its useful need.Additional information was requested.
Additional Manufacturer Narrative
A review of complaint history, device history record, instructions for use (ifu), manufacturing instructions, specification and quality control data was conducted during the investigation.One complaint device was returned for investigation; a visual examination noted the tubing is partially separated at the purple hub and the tubing is partially separated at the white hub.The failure originated at the molded transition between the silicone extension tubing and over-molded plastic hub.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The turbo-ject® double lumen bedside power-injectable picc is shipped with instructions for use (ifu) which clearly state the proper warnings, precautions, and instructions for use with each device.The ifu specifically states, ¿extreme caution must be used in placement and monitoring.Silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10 ml syringe or larger will reduce the risk of catheter rupture.If lumen flow is impeded, do not force injection or withdrawal of fluids.Catheter size should be as small as the use will allow.¿ based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A thorough review of the device history record did not observe any non-conformances that may have contributed to this incident associated with the complaint lot number 7571792.A complaint history search for similar complaints revealed this record to be the only reported complaint associated with the complaint lot number.Based on the provided information, inspection of returned product and the investigation, a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.As per the health risk assessment, no further action is required.

• Brand Name: TURBO-JECT® DOUBLE LUMEN BEDSIDE 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: 6725353
• Report Number: 1820334-2017-01750
• Device Sequence Number: 16466548
• Product Code: LJS
• UDI-Device Identifier: 00827002237155
• UDI-Public: (01)00827002237155(17)190108(10)7571792
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K072625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2017

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-4.0-CT-40NT-1110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 10/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR