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

Catalog Number 003-40F

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if the device sample is available for evaluation.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.A device history record review could not be conducted since the lot number was not provided.Regarding this issue a capa file (b)(4) was opened.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.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.If device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the adaptor with the manometer broke and an oxygen leak was noticed.The patient desaturated while the defective device was being replaced.

• Brand Name: HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE
• 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: 5147498
• MDR Text Key: 28647807
• Report Number: 1417411-2015-00165
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 10/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 003-40F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2015
• 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