MAUDE Adverse Event Report: CAREFUSION, INC THORACENTESIS TRAY 14G X 2 W/CATH; NEEDLE, CATHETER

Model Number 4341B

Device Problem Air Leak (1008)

Patient Problem Adult Respiratory Distress Syndrome (1696)

Event Date 02/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) upon carefusion/bd evaluation, a follow up emdr will be submitted.(b)(4).Additional information received: is the patient still intubated? if no, when was he/she extubated? unknown were medications needed during the cpr? if yes, what was given? (please include concentration, dose, rate,route) unknown will the patient¿s stay in the hospital be extended due to this incident? unknown do you have a sample available for evaluation? if yes, i will forward a shipping label and biohazard container if needed.Yes, (b)(4) (b)(6) 2016.Were there any visible issues with the thoracentesis kit? unknown are you able to find out what the lot number was of this kit? no.If you are unable to provide any of this information, can you provide contact info for someone who can? n/a.In addition to the below questions, can you find out if there was any difficulty in setting up the thoracentesis? could the lines have been attached backwards? unknown.

Event Description

Thoracentesis catheter 5fr x 7in that "patient was undergoing thoracentesis using catheter from carefusion thoracentesis tray with catheter, cat 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 g used to decompress chest.Sats and hr quickly recovered; patient then intubated and chest tube placed.Cxr confirmed clinically-suspected pneumothorax.".

Manufacturer Narrative

(b)(4).Follow up emdr submission for device evaluation.Two functional tests were performed on the returned sample.One included crimping the catheter and applying pressure via attached syringe.No air leaks were indicated.The second test involved drawing water into an attached syringe and again applying pressure with the catheter kinked.No water leakage occurred; therefore the reported failure cannot be confirmed.No lot information was provided for this complaint.Consequently, a dhr review could not be performed.Root cause could not be confirmed since the evaluation of the complaint sample could not confirm the reported failure mode and no lot information were provided for review.No additional action will occur based on the results of the sample evaluation.This complaint will be entered into the complaint management system and tracked/trended for future occurrences.

• Brand Name: THORACENTESIS TRAY 14G X 2 W/CATH
• Type of Device: NEEDLE, CATHETER
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628063
• MDR Report Key: 5436005
• MDR Text Key: 38221888
• Report Number: 1625685-2016-00229
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4341B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2016
• 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): Required Intervention
• Patient Age: 75 YR