MAUDE Adverse Event Report: CAREFUSION 2200, INC. THORACENTESIS NEEDLE CATHETER TRAY; NEEDLE, CATHETER, THORACENTESIS TRAY

Model Number 4341B

Device Problem Air Leak (1008)

Patient Problems Aspiration/Inhalation (1725); Low Blood Pressure/ Hypotension (1914); Pneumothorax (2012); Loss Of Pulse (2562)

Event Date 08/08/2015

Event Type  Injury  

Event Description

Patient was undergoing thoracentesis using catheter from carefusion thoracentesis tray with catheter, catalog number 4341b.During the placement, it was noted that air was aspirating despite the needle being inserted inside the skin.Shortly thereafter patient's blood pressure dropped and pulse lost.Airway managed, short cpr, 14 gauge used to decompress chest.Sats and hr quickly recovered; patient then intubated and chest tube placed.Chest x-ray confirmed clinically-suspected pneumothorax.More info: thoracentesis catheter, being placed for iatrogenic pneumothorax, did not function as expected (air leak - md does not believe it was user error).Biomed paged to retrieve device.Pt.Has lung cancer on same side.Intubation would have occurred despite suspected catheter malfunction.

• Brand Name: THORACENTESIS NEEDLE CATHETER TRAY
• Type of Device: NEEDLE, CATHETER, THORACENTESIS TRAY
• Manufacturer (Section D): CAREFUSION 2200, INC.; 400 east foster road; mannford OK 74044
• MDR Report Key: 5480477
• MDR Text Key: 39685230
• Report Number: 5480477
• Device Sequence Number: 1
• Product Code: GCB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2015,01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 4341B
• Device Catalogue Number: 4341B
• Device Lot Number: UNKNOWN
• Other Device ID Number: 5 FR X 7 IN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 59