MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON RESERVOIR,CONCHA MINI 760 ML; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number 381-52

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.Review of manufacturing event log shows no issues that may have contributed to any quality issues reported.All process parameters were within specification.All in-process qa inspections were acceptable.No sample available from the customer to investigate.Complaint cannot be confirmed based on the information received.Root cause is unknown.If the device sample becomes available, this report will be updated with the evaluation results.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

Customer complaint alleges that pressure from the bottle causes the tubing from the column to pop out.Customer reports "this happened on 2 bottles.One was situated correctly in the bracket with the "knob" of the bottle on the bottom of the bracket.The other the "knob" of the bottle was on the top of the bracket." (other reported event captured in companion report (b)(4).Alleged issue reported as occurred during a patient use.It was reported there was no patient injury or consequence.The patient condition was reported as "fine".

Manufacturer Narrative

(b)(4).An empty 760 ml water bottle, lot # 039140, was received for investigation.The water bottle had both top and bottom ports punctured.Upon visual inspection no issues were found.A functional inspection could not be performed as the concha column was not received along with the complaint sample.A visual inspection of the product involved in the complaint did not show any defects.Without the concha column present to test fun ctionality, a defect could not be confirmed.Additionally, the sample received for this complaint had an expiration date of 02-2018, four months prior to the complaint date.

Event Description

Customer complaint alleges that pressure from the bottle causes the tubing from the column to pop out.Customer reports "this happened on 2 bottles.One was situated correctly in the bracket with the "knob" of the bottle on the bottom of the bracket.The other the "knob" of the bottle was on the top of the bracket." (other reported event captured in companion report (b)(4).) alleged issue reported as occurred during a patient use.It was reported there was no patient injury or consequence.The patient condition was reported as "fine".

• Brand Name: HUDSON RESERVOIR,CONCHA MINI 760 ML
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7620922
• MDR Text Key: 112161134
• Report Number: 1417411-2018-00046
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

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: 02/28/2018
• Device Catalogue Number: 381-52
• Device Lot Number: 039140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 08/03/2018
• Supplement Dates FDA Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1