MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CIRCUIT,(22MM),KRATON,DUAL HTD LIMBS; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number 790-32

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has been received by the manufacturer.However, the investigation of said device is still in progress at the time of this report.The device history record (dhr) of batch number (b)(4) that belongs to catalog number 790-32 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.The dhr shows that the product was assembled and inspected according to our specifications.A follow up report will be submitted at the conclusion of the device investigation.

Event Description

Customer complaint alleges the device leaked during the short service test on the ventilator.Customer reports there was no patient involvement.

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.In addition, no dimensional issues were identified.The sample met the current manufacturing specification.Functional testing was performed and the sample failed the leak test.The sample was then submerged in water and bubbles were observed, confirming there was a leak.The customer complaint is confirmed based on the functional inspection.The sample did not pass the leak test.A non-conformance report was initiated to complete and document the investigation and to provide corrective actions.

Event Description

Customer complaint alleges the device leaked during the short service test on the ventilator.Customer reports there was no patient involvement.

• Brand Name: HUDSON CIRCUIT,(22MM),KRATON,DUAL HTD LIMBS
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7146175
• MDR Text Key: 95847217
• Report Number: 3004365956-2017-00469
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

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 Catalogue Number: 790-32
• Device Lot Number: 74E1700107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2017
• Initial Date FDA Received: 12/26/2017
• Supplement Dates Manufacturer Received: 01/31/2018
• Supplement Dates FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• 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