MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON 22MM DUAL HTD CIRC KIT; RESPIRATORY GAS HUMIDIFIER

Catalog Number 870-35KIT

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Three pictures of product p/n 870-35kit (22mm dual htd circ kit) were received for analysis.They were visually inspected, finding in one of the pictures a component with tape as is describe in this customer complaint description.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.A device history record review could not be conducted since the lot number was not provided.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.If the device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the circuit disconnected at the "y" during use.No patient injury reported.

• Brand Name: HUDSON 22MM DUAL HTD CIRC KIT
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5412751
• MDR Text Key: 37542589
• Report Number: 3004365956-2016-00109
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 870-35KIT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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