MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX THORACIC CATHETER SELDINGER CHEST DRAINAGE KIT

Model Number 200/910/120

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pneumothorax (2012)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

Reporter occupation : oa chirug intensive.Foreign : (b)(6).

Event Description

Information was received that a smiths medical portex thoracic catheter seldinger chest drainage kit was in use with a patient.Immediately on use, it was reported the device tore off between luer lock port and catheter.Subsequently, the patient developed a tension pneumothorax and it was necessary to lay a chest tube.No additional adverse patient effects were reported.

Manufacturer Narrative

Device evaluation: one unopened kit from the reported lot was returned for investigation.The affected sample was not provided.The complaint was discussed to establish which of the components within the kit would most likely have contributed to the issue experienced by the customer.Three components were identified, a dilator, catheter sub assembly, and a four way stopcock.The dilator component was inspected against the requirements and passed all inspections.Upon visual inspection of the other components, no deviations were found.The pleuralcatheter was connected to the stopcock without any problems.Furthermore, a tensile test of the connection catheter tube-luer was performed on the returned pleuralcatheter and found no issues.Additionally, the brittleness of the luer was tested with a torque meter and during production is 100% tested for cracks or damage.No discrepancies were identified.Based on the evidence and testing, the complaint could not be confirmed.The investigation results further noted the reported failure was noticed during usage and that likely procedural and clinical factors impacted the reported event.

• Brand Name: PORTEX THORACIC CATHETER SELDINGER CHEST DRAINAGE KIT
• Type of Device: CHEST DRAINAGE KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9292547
• MDR Text Key: 165572313
• Report Number: 3012307300-2019-05948
• Device Sequence Number: 1
• Product Code: PAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 200/910/120
• Device Catalogue Number: 200/910/120
• Device Lot Number: 3832304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention