MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE; HUMIDIFIER NEBULIZER KIT

Catalog Number 003-40F

Device Problems Break (1069); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint was not returned to the manufacturer for evaluation.Based on the lot 18b136 provided, for which the device history record 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 during the manufacture of the material.Customer complaint cannot be confirmed based only on the information provided.To perform a proper investigation and determine the source of alleged defect reported it is necessary to evaluate the sample involved.If the device sample becomes available at a later date this report will be updated with the evaluation results.Teleflex will continue to monitor customer feedback for complaints of this nature.

Event Description

Customer complaint alleges the device component tightening ring is too fragile, it breaks causing an oxygen leak.Alleged issue reported occurred during a patient use.It was reported there were no consequences for the patient.Patient condition reported as "fine".

• Brand Name: HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE
• Type of Device: HUMIDIFIER NEBULIZER KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 7732792
• MDR Text Key: 115478840
• Report Number: 1417411-2018-00078
• Device Sequence Number: 1
• Product Code: OGG
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/08/2022
• Device Catalogue Number: 003-40F
• Device Lot Number: 18B136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2018
• 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