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

Device Problem Material Separation (1562)

Patient Problems Foreign body, removal of (2365); Surgical procedure, additional (2564)

Event Date 01/11/2015

Event Type  Injury  

Event Description

The doctor and resident were performing a pediatric surgery at the bedside to remove the central line before the patient went home.An rn was holding the baby for the procedure while the doctor was removing the central line.The line broke and part of the line remained inside of the baby.Additional information provided via email: "the device was placed off of our unit and the patient lond discharged.The patient did in fact have to return to the operating room for removal of the piece of catheter.However, the piece was so adhered into the vessel that in the 24 hours after the catheter broke and the patient went to surgery, the piece in question never moved.This was a tunneled central line placed via the svc, so was in the chest.The patient discharged within 2-3 days of removing the broken piece." information was not provided regarding the patient outcome.

Manufacturer Narrative

D4: lot number not provided by the reporter.Catalog # not provided by the reporter.Expiration date unknown as lot is unknown.Udi # unknown as lot is unknown.F9: unknown as lot is unknown.(b)(4).Corrected data from user facility report.

Manufacturer Narrative

No product was returned to assist in the investigation.A review of the complaint history, instructions for use (ifu) and quality control (qc) was conducted during our investigation.The integrity of this device is inspected, which includes, checking the surface of the tubing for imperfections and confirming the overall catheter surface is dean without excessive imperfections or damage.This product is shipped with an instructions for use (ifu), which states warnings, precautions and instructions for use.As no product was returned for evaluation, based on the event description, we are unable to determine with certainty the root cause for the reported difficulty.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per quality engineering risk assessment (qera) no further risk reduction is required.

• Brand Name: COOK TPN SINGLE LUMEN TPN CATHETER SET
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4665288
• MDR Text Key: 16467253
• Report Number: 1820334-2015-00180
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2015

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/11/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/06/2015
• Initial Date FDA Received: 04/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 2 MO