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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the bottle wouldn't puncture." no patient involvement reported.

Event Description

It was reported "the bottle wouldn't puncture." no patient involvement reported.

Manufacturer Narrative

Qn# (b)(4).One empty 381-50, 1650 ml, reservoir lot 20a071 was received for evaluation."1a" was embossed in the plastic of the bottom of the reservoir.The reservoir arrived with both ports punctured.The top and bottom ports on the reservoir were inverted such that the ports had not ruptured cleanly.No other visual defects were observed.A conchasmart column lot 74b2000031 was also received for evaluation.The column's protective caps and sheaths were not received.In review of the reservoir lot's device history record: manufacturing event logs showed no issues that may have contributed to the quality issue reported; process parameters were within specification; and qa inspections were acceptable, including port penetration tests.In functional inspection of the conchasmart column received in the complaint, both ports on an unrelated 381-50 test sample punctured cleanly.Port inversion may be due to improper spike technique by a user (per product label, "push and twist the puncture pins through the puncture sites").An attempt was made to recreate the failure mode using the column returned and a non-complaint 381-50 test reservoir of a different lot.The failure mode was recreated by pushing a puncture pin in a port without twisting.Complaint "the bottle wouldn't puncture" may be due to the user pushing the spike into the port without twisting.Root cause of complaint inability to pierce reservoir bottle is unknown.Complaint cannot be confirmed as related to manufacturing.

• Brand Name: HUDSON CONCHA 1500 SW 1650 ML
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 11047183
• MDR Text Key: 222781287
• Report Number: 1417411-2020-00044
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/20/2024
• Device Catalogue Number: 381-50
• Device Lot Number: 20A041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2020
• 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