MAUDE Adverse Event Report: CAREFUSION THORACENTESIS/PARACENTESIS TRAY; NEEDLE, CATHETER

Model Number TPT1000

Device Problems Air Leak (1008); Improper or Incorrect Procedure or Method (2017)

Patient Problem Pneumothorax (2012)

Event Date 10/28/2015

Event Type  Injury  

Manufacturer Narrative

Cfn-2015-6784: initial emdr submission.A follow up emdr will be submitted upon completion of investigation.

Event Description

Medical specialties - customer dissatisfaction customer reported via email: a fellow used our tpt1000.They hooked up the "push/pull method" incorrectly.They hooked the longer end of the line to the syringe, and the shorter end to the bag.After they realized it, they hooked it up correctly, but they had already introduced some air into the patient causing a small pnemo.They put a chest tube in the patient to drain the air.Patient is now okay.They believe our ends of the line should be color coated.I am still trying to get a sample off the shelf, but they do not know if it was the same lot number.Additional information received 16nov2015: can you provide any patient info? (i.E.Initials, age, gender, diagnosis, hx) (b)(6) male with end stage lung cancer admitted with superior vena cava syndrome ࠈow long was the chest tube in place? overnight (verbally stated from resident) is there a sample available for evaluation? no, i did not hear about this issue until after the patient was gone.Do you have a lot number? no way to know.

Manufacturer Narrative

(b)(4).Follow up emdr submission for device evaluation.A sample was not returned for analysis.Therefore a defect could not be identified.A lot number was not identified for the reported failure.A sample was not returned for analysis.A lot number was not reported with the complaint, so a device history record could not be investigated.The trending report did not indicate an adverse trend with the product.Therefore, a root cause could not be established.A defect could not be identified as both a sample and lot number was not provided.Therefore, corrective actions are not indicated.

• Brand Name: THORACENTESIS/PARACENTESIS TRAY
• Type of Device: NEEDLE, CATHETER
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC; 400 east foster rd; mannford 74044
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 5230468
• MDR Text Key: 31412396
• Report Number: 1625685-2015-00221
• Device Sequence Number: 1
• Product Code: GCB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: TPT1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR