MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HUMIDIFIER ADAPTOR,040 SHELF PAK,FRENCH

Catalog Number 000-40F

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

Patient Problems Cyanosis (1798); Dyspnea (1816); No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if the device sample is available for evaluation.(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 cl12 provided for which the dhr resides at (b)(6) facility, the (b)(4) lot numbers for component 12228 were obtained.Records reviewed showed that there were no issues related to functional issues on the molded component involved in this complaint.No corrective action can be established at this moment since the device sample or pictures of it are not available for evaluation.Customer complaint cannot be confirmed based only on the information provided, to perform an 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 available at the facility and it is not being manufactured at the time.If device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the plastic adaptor of the aquapak was found broken and there was an oxygen leak.The device was replaced.

• Brand Name: HUDSON HUMIDIFIER ADAPTOR,040 SHELF PAK,FRENCH
• Type of Device: ADAPTOR
• 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: 5024640
• MDR Text Key: 24703087
• Report Number: 1417411-2015-00140
• 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
• Report Date: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 000-40F
• Device Lot Number: CL 12 2019/1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2015
• 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