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

Catalog Number 381-50

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported the respiratory therapist was unable to spike the bottle on the bottom hole and the plastic stretches, prior to use.No patient involvement reported.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.In the device history record review of the reported 381-50 lot 19a141, manufacturing event logs showed no issues that may have contributed to the quality issue reported, and process parameters were within specification.A possible manufacturing cause of the present bottom-port complaint is a combination of improper blow pressure and vacuum during manufacturing, which may result in uneven plastic distribution such that the top port is thin, and the bottom port is thick.In-process qa inspections in the device history record show one nonconformance report (nr) that may have some impact on the present complaint: nr for top port leaks.Cause of top port leak nr was "blow issues" corrected by "adjusted blow pressure".Improper blow pressure and vacuum during manufacturing may result in uneven plastic distribution such that the top port is thin, and the bottom port is thick.Nonconforming material was sorted for top port leak.Bottles were re-inspected and found to be acceptable per internal specification.Complaint bottle and puncture pin sample are not available from the customer to investigate.Complaint "unable to spike the bottle on the bottom hole" and "the plastic just stretches" may be due to the user pushing the spike into the port without twisting.Label l02546 r00 for product 381-50 includes, "push and twist the puncture pins through the puncture sites." plastic stretching may also result from use of a dull puncture pin.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer reported the respiratory therapist was unable to spike the bottle on the bottom hole and the plastic stretches, prior to use.No patient involvement reported.

• Brand Name: HUDSON CONCHA 1500 SW 1650 ML
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 9774628
• MDR Text Key: 199083833
• Report Number: 1417411-2020-00011
• 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: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/16/2023
• Device Catalogue Number: 381-50
• Device Lot Number: 19A141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1