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

Catalog Number 003-40

Device Problems Air Leak (1008); Connection Problem (2900)

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

Event Date 11/12/2015

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.Based on the lot 277157 provided for which the dhr resides at (b)(4) facility, the (b)(4) lot numbers for component (b)(4) were obtained.Records reviewed showed that there were no issues related to functional issues on the molded component involved in this complaint (b)(4) (snap-on flowmeter adaptor) batch 2-1115741, 2-1115742, 3-1115741 & 7-1015741 during the manufacture of the material.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.An attempt to duplicate the failure mode was made, but at the time there is no inventory of the involved product code 003-40 (aquapak 340 sw, 340 ml w/040 adaptor) available at the facility and it is not being manufactured at the time; however, regarding other customer complaints from this same issue, a capa file #(b)(4) was opened to perform a further investigation this issue (this capa is owned by (b)(4)).Other remarks: according to the capa investigation so far the root cause for the issue was the positioning of the thread 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 there is an air escape and the screw cap connector does not screw onto the wall oxygen outlet correctly.No report of a patient injury.

• 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: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5235544
• MDR Text Key: 31586512
• Report Number: 1417411-2015-00170
• 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
• Type of Report: Initial
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 003-40
• Device Lot Number: 277157
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2015
• 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