MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHA 1500 SW 1650 ML; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number 381-50

Device Problems Fluid/Blood Leak (1250); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported the water bottle leaked from the top puncture port.It was reported the bottle port did not puncture all the way.No patient harm or consequence reported.Patient condition reported to be "fine".

Manufacturer Narrative

(b)(4).One empty 1650 ml water reservoir lot: 19a145 was received for evaluation.The water bottle arrived with both ports punctured: the top port was punctured cleanly without port inversion; the bottom port was inverted such that the port did not rupture cleanly.Complaint "incomplete puncture" confirmed as reported.In review of device history record, manufacturing event log shows no issues that may have contributed to any quality issues reported.All process parameters were within specification, and all qa inspections were acceptable.A sample of the spike used on the sample's bottom port is needed for further investigation.Port inversion can occur due to a dull spike.Port inversion can also be due to improper spike technique by a user (per instructions for use, connect the tube to the port "by piercing the port with spike using a twisting motion").Root cause unknown.A non-conformance was opened to further address this issue.

Event Description

Customer reported the water bottle leaked from the top puncture port.It was reported the bottle port did not puncture all the way.No patient harm or consequence reported.Patient condition reported to be "fine".

• Brand Name: HUDSON CONCHA 1500 SW 1650 ML
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9682881
• MDR Text Key: 201572345
• Report Number: 1417411-2020-00003
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K760866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/22/2023
• Device Catalogue Number: 381-50
• Device Lot Number: 19A145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.