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 Codes	Hole In Material (1293); Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During the flushing of the line the patient felt a pop followed by some pain in the neck.A linogram showed leaking of contrast from the line due to a small hole in the line.The line was removed and a picc line inserted instead.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of complaint history, device record history, instructions for use (ifu), manufacturing instructions, documentation, quality control and a visual inspection of the returned device was conducted during the investigation.The visual examination reported the device showed signs of usage and a rupture was observed in the catheter.The manufacturing record for this lot was reviewed, and nothing of note was observed.It should be noted that there are no other complaints of any nature associated with this lot.The complaint was confirmed based on the findings of the returned product.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.The device is shipped with an (ifu) that describes the intended use, specific items are addressed such as: warnings: "if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify the attending physician immediately." precautions: "silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10ml syringe or large will reduce the risk of catheter rupture." "suggested catheter maintenance" is provided within the ifu which includes reference to the use of saline for flushing and creating a lock." the appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.
Event or Problem Description
During the flushing of the line, the patient felt a pop followed by some pain in the neck.A linogram showed leaking of contrast from the line due to a small hole in the line.The line was removed and a picc line inserted instead.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects 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: 5694366
• Report Number: 1820334-2016-00365
• Device Sequence Number: 13481572
• Product Code: FOZ
• UDI-Device Identifier: 00827002294646
• UDI-Public: (01)00827002294646(17)181206(10)6348112
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2016

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-9.0D-90-REDO
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/04/2016
• Device Age: 2 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2016
• Supplement Report FDA Received Date: 06/27/2016
• 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