MAUDE Adverse Event Report: COOK INC REDO DOUBLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Catalog #: c-tpns-7.0d-65-redo (based on the lot # provided by the user facility).(b)(4).The event is currently under investigation.
Event or Problem Description
Per user facility medwatch report received 28 january 2016: patient's double lumen broviac line located on his left chest wall, when flushed, (to prepare administration of chemotherapy) broke.Fluid began leaking above the bifurcation point when flushed.The line was not leaking while iv fluids were infusing moments prior.Line was not flushed with excessive force or pulled to create a weakened spot.The line was immediately held closed, stat locks and sterile gauze applied over the hole and the line held closed with the stat lock.No leaking present after that.Physician notified, physician then notified the surgical team.Patient will have broviac line removed tomorrow (date not specified) and have a pac put in place.This is the 3rd time this has happened to this patients line.The product was not retained.A section of the device did not remain inside the patient's body.The patient will have a broviac line removed and have a pac put in place due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects other than the additional surgery due to this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of complaint history, drawing, instructions for use (ifu), manufacturing instructions, and quality control was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: "extreme caution must be used in placement and monitoring." the complaint device was not returned therefore, no physical examinations could be performed; however, 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.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the risk assessment (ra) no further action is required.
Event or Problem Description
Per user facility medwatch report received 28 january 2016: patient's double lumen broviac line located on his left chest wall, when flushed, (to prepare administration of chemotherapy) broke.Fluid began leaking above the bifurcation point when flushed.The line was not leaking while iv fluids were infusing moments prior.Line was not flushed with excessive force or pulled to create a weakened spot.The line was immediately held closed, stat locks and sterile gauze applied over the hole and the line held closed with the stat lock.No leaking present after that.Physician notified, physician then notified the surgical team.Patient will have broviac line removed tomorrow (date not specified) and have a pac put in place.This is the 3rd time this has happened to this patients line.The product was not retained.A section of the device did not remain inside the patient's body.The patient will have a broviac line removed and have a pac put in place due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects other than the additional surgery due to this occurrence.

• Brand Name: REDO DOUBLE LUMEN TPN CATHETER SET
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5435823
• Report Number: 1820334-2016-00074
• Device Sequence Number: 530694
• Product Code: FOZ
• UDI-Device Identifier: 00827002079021
• UDI-Public: (01)00827002079021(17)180706(10)5959411
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2016
• Report Date (Section F): 01/19/2016

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-7.0D-65-REDO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/08/2016
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2016
• Supplement Report FDA Received Date: 08/12/2016
• 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: 9 MO
• Patient Weight: 10
• Date Report Sent to FDA: 01/19/2016