MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CENTESIS PROCEDURE TRAY 6F X 16CM SKATER SAFETY CENTESIS CATHETER

Catalog Number APIG1260T

Device Problem Gas/Air Leak (2946)

Patient Problem Pneumothorax (2012)

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device is available for evaluation.Argon will continue to request its return.A follow-up report will be provided once more information is available.

Event Description

Centesis procedure tray, 6f x 16 cm skater safety centesis catheter with pigtail and blunt retracting stylet lot 11310164 complication of a thoracentesis in which the one-way valve on the end of the catheter failed and allowed air to enter the chest and the collection bottle.With the end of the catheter manually occluded no more air entered and the procedure was completed though there was a significant pneumothorax.

Event Description

Follow up.

• Brand Name: CENTESIS PROCEDURE TRAY 6F X 16CM SKATER SAFETY CENTESIS CATHETER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10449366
• MDR Text Key: 204247760
• Report Number: 1625425-2020-00493
• Device Sequence Number: 1
• Product Code: GBQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: APIG1260T
• Device Lot Number: 11310164
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other