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

Catalog Number	UPICDS-5.0-CT-NT-ABRM-1111
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/04/2018
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 a turbo-ject® double lumen minocycline/rifampin power-injectable picc placed in arm was found leaking at the hub on (b)(6) 2018.The line was removed and another device was placed.To date, additional patient, device and event information has been requested from the facility but not yet provided.As reported, the patient did not experience any adverse effects due to his occurrence, however, a second procedure was required to replace the device.
Additional Manufacturer Narrative
Blank fields on this form indicate the information has previously been reported, is unknown or is unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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.
Event or Problem Description
Additional information was received with the receipt of device on(b)(6) 2018.The device was placed in the right basilica vein on (b)(6) 2018 and removed on (b)(6) 2018 due to leaking observed at the white lumen.The device was utilized for blood products, chemo and labs.Patient demographics and device information were also provided.
Additional Manufacturer Narrative
Device evaluation the reported used device was returned to cook inc.For evaluation.Visual inspection verified a 1.6cm "burst" noted from the distal tip of the 28.2cm catheter.The burst/bulge is approximately 0.9cm in length.Functional testing of the device determined the lumen was occluded and therefore over pressurized and "burst".Investigation a document-based investigation reviewed the following: instructions for use, quality control, drawings, manufacturing instructions, device history record and complaint history.There is no evidence to suggest the finished product was not made to specifications.A review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.Conclusion based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.It is unknown what led to the occlusion.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.
Event or Problem Description
See h10.

• Brand Name: TURBO-JECT® DOUBLE LUMEN MINOCYCLINE/RIFAMPIN 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: 7997040
• Report Number: 1820334-2018-03081
• Device Sequence Number: 16250257
• Product Code: LJS
• UDI-Device Identifier: 00827002239135
• UDI-Public: (01)00827002239135(17)190712(10)8633089
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2019

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: 07/12/2019
• Device Catalogue Number: UPICDS-5.0-CT-NT-ABRM-1111
• Device Lot Number: 8633089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 10/22/2018; 12/11/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/21/2018; 01/10/2019
• 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
• Patient Age: 14 YR