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

Catalog Number	UPICDS-4.0-CT-40NT-1111
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported the purple hub on a turbo-ject® double lumen bedside power-injectable picc was found cracked.This lumen was being used to infuse total parenteral nutrition(tpn.) the device was removed and replaced during an additional procedure.It is unknown how long the device was in place and when it was removed.As reported, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested with regards to the device, event, and patient details but have not been provided at the time of this report.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information has previously been reported, is unknown or is unavailable.Device evaluation: one device was returned to the manufacturer for evaluation.Visual exam notes clear tubing is partially separated at the purple hub.Additionally, a document based investigation evaluation was performed.Investigation: a document-based investigation reviewed the following: instructions for use, quality control specifications, documentation, and complaint history.There is no evidence to suggest the product was not made to specifications.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Review of device history record did not observe any nonconformances that may have contributed to this incident.A search of the manufacturer's complaint database identified this complaint to be the only one associated with complaint lot number 9101421.Risk assessment determined that risk controls are in place to mitigate this failure mode.The appropriate personnel were notified, and we will continue to monitor for similar complaints.Conclusion: based on the information provided, the device evaluation and the results of our investigation, the root cause was determined as cause traced to device design (design inadequate for purpose).Appropriate measures have been initiated to address this failure mode.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 8116416
• Report Number: 1820334-2018-03414
• Device Sequence Number: 1553086
• Product Code: LJS
• UDI-Device Identifier: 00827002345119
• UDI-Public: (01)00827002345119(17)200816(10)9101421
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2020
• Device Catalogue Number: UPICDS-4.0-CT-40NT-1111
• Device Lot Number: 9101421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/17/2019
• 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