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 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported, "they had a bottle that they couldn't puncture the top water port," prior to use on patient.No patient involvement reported.

Event Description

It was reported "they had a bottle that they couldn't puncture the top water port" prior to use on patient.No patient involvement reported.

Manufacturer Narrative

(b)(4).One empty 381-50, 1650 ml, reservoir lot 20a092 was received for evaluation."2a" was embossed in the plastic of the bottom of the reservoir.The reservoir arrived with both ports punctured.The bottom port had been punctured cleanly without port inversion.The top port on the reservoir was inverted such that the port had not ruptured cleanly.No other visual defects were observed.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.A sample of the puncture pin used on the sample's top port is needed for further investigation.Port inversion can occur due to a dull puncture pin.Port inversion can also be due to improper spike technique by a user (per product label, "push and twist the puncture pins through the puncture sites").Complaint "couldn't puncture the top water port" may be due to the user pushing the spike into the port without twisting.No column sample is available from the customer, so complaint inability to pierce reservoir bottle cannot be suitably investigated.Root cause is unknown.

• Brand Name: HUDSON CONCHA 1500 SW 1650 ML
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 11065058
• MDR Text Key: 223400491
• Report Number: 1417411-2020-00046
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/05/2024
• Device Catalogue Number: 381-50
• Device Lot Number: 20A092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 02/05/2021
• Supplement Dates FDA Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2020
• 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