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

Catalog Number 870-35KIT

Device Problems Loss of or Failure to Bond (1068); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A conclusion code could not be chosen.The complaint was confirmed, but the root cause is unknown.The device history record of batch number (b)(4) that belongs to catalog number 870-35kit has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.Upon receipt the circuit was visually examined for any signs of damage, abuse/misuse.It was noted that the connector on the expiratory side of the limb, which attaches to the filter of the ventilator was loose and easily removed.The complaint has been confirmed.Functional inspection - when the connector was pushed firmly back onto the circuit tubing it stayed in place and would not detach without using a significant amount of pulling force.The investigation revealed a loose connector on the expiratory side of the limb.Other remarks: root cause cannot be determined.There are several speculative scenarios that should be mentioned regarding this complaint.First, the complaint description states that the connectors became unglued.These connectors are not glued.They are press fitted onto the circuit with an alcohol lubricant/sealant.Secondly, this connector is handled more frequently than the other connectors because it is attached to the ventilator filter which is changed daily.This end of the expiratory limb must be detached in order to change the ventilator filter which requires more opportunities for this connector to be handled and work loose.No further action required.

Event Description

The customer alleges that the circuit came unglued where the expiratory corrugated tubing connects to the hard plastic piece.The circuit was in use for approximately 22 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: 5453784
• MDR Text Key: 38775219
• Report Number: 3004365956-2016-00130
• 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: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• 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: 74M1500851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2015
• 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
• Treatment: HAMILTON G5 VENTILATOR