MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR; RESPIRATORY GAS HUMIDIFIER

Catalog Number 003-40

Device Problem Leak/Splash (1354)

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

Event Date 08/06/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not received at our facility.The device history record review showed no issues related to functional issues on mold component involved in this complaint.Customer complaint cannot be confirmed, based only on the information provided, to perform a correct investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.Regarding other customer complaints for this same issue, a capa file #(b)(4) was opened to perform a further investigation into this issue (this capa is owned by (b)(4)).According to the capa investigation so far the root cause for the issue was the positioning of the thread lead and the softness of the new resin used for the snap adaptor.If device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the oxygen is leaking at the screw mechanism.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the internal threads of the adaptor were damaged.Based on the visual exam, the reported complaint was confirmed.The root cause for the issue was found to be the positioning of the thread lead and the softness of the new resin used for the snap adaptor.A capa was opened to address this issue.

Event Description

The customer alleges that the oxygen is leaking at the screw mechanism.

• Brand Name: HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5257898
• MDR Text Key: 32399662
• Report Number: 1417411-2015-00174
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 003-40
• Device Lot Number: 568147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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