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

Catalog Number 870-35KIT

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation code conclusion(s) - a conclusion code could not be chosen.The complaint was confirmed, via visual/photo inspection, but the root cause is unknown.One picture of product p/n 870-35kit (22mm dual htd circ kit) was received for analysis.It was visually inspected, finding the connection of the elbow p/n tfx-000149 with the corrugated tubing p/n 161050-03 detached.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.The customer complaint was confirmed based on the visual inspection of the received picture, because of connection detachment of the elbow p/n tfx-000149 with the corrugated tubing p/n 161050-03 detached.Although the complaint is confirmed based on the picture provided, there is no sufficient evidence to assure this issue was originated during the manufacturing process.Other remarks: the root cause for the condition reported could not be identified.To perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.However, 29 samples of current production p/n 870-35kit (22mm dual htd circ kit) were reviewed and inspected performing a subjective pull test to these connections and no issues were found that can lead to the condition reported by the customer.If the device defective sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the circuit came unglued where the expiratory corrugated tubing connects to the hard plastic piece.The alleged issue was observed after a vent disconnect alarm was triggered (during change out of expiratory filter).The circuit was in use for approximately 27 days.No patient harm 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: 5448374
• MDR Text Key: 38638706
• Report Number: 3004365956-2016-00126
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• 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: 02/08/2016
• 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