MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MASK,MULTI-VENT,ADULT; OXYGEN MASK

Catalog Number 1088

Device Problems Incorrect Device Or Component Shipped (2962); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/29/2015

Event Type  malfunction  

Event Description

The customer alleges that when preparing the device for use, the connector was incorrect and there was a lack of mist.

Manufacturer Narrative

(b)(4).A visual inspection of the prod involved in the complaint could not be conducted since the prod or a picture of the defect was not provided.However, current production samples of catalog number 1088 batch number 74d1502817 were inspected and no issues were found than can lead to the condition reported by the customer.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the prod was not returned.The device history record review showed that there were no issues related to this issue neither on the prod nor its components during the mfg of the material.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.Add'l info is required in order to investigate which of the components is the incorrect one.Customer complaint cannot be confirmed without sample.If the device sample becomes available this investigation will be updated with the eval results.

Manufacturer Narrative

(b)(4).One sample of catalog number 1088 mask, multi-vent, adult was received for analysis.A visual exam was performed and it was observed that the sample was not in the original packaging.No other issues were observed.The instructions for use (ifu) states that if humidification is desired, use the high humidity adaptor and connect the adaptor to the humidity source with large bore tubing, which is not supplied with the kit.The customer complaint could not be confirmed as the required components for the humidification test are not supplied with this catalog number and the received sample was not in the original packaging.Based on this, it is not possible to establish a corrective action since the customer complaint could not be confirmed.The root cause for the condition reported could not be identified.However, regarding this issue all personnel from the production line were notified.

Event Description

The customer alleges that when preparing the device for use, the connector was incorrect and there was a lack of mist.

• Brand Name: HUDSON MASK,MULTI-VENT,ADULT
• Type of Device: OXYGEN MASK
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 8827 5; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4752217
• MDR Text Key: 5827085
• Report Number: 3004365956-2015-00138
• Device Sequence Number: 1
• Product Code: BYG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1088
• Device Lot Number: 02D1300743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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