MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADAPTOR,040 HUM,INTL; NEBULIZER ADAPTOR

Catalog Number 400040

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reported potential lot number: 26g15 or 26j15.A visual, functional, and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.Lot 26j15 is not a valid lot number.A device history record review was performed for lot 26g15.The review of manufacturing event log showed no issues that may have contributed to any quality issues reported.All process parameters were within specification.All in-process qa inspections were acceptable.All post sterility and package integrity tests were acceptable.No sample available from the customer to investigate.Complaint not confirmed.Root cause unknown.Teleflex will continue to monitor feedback from the customers on issues related to water leaked into nasal oxygen supply.

Event Description

The customer alleges that water from the aquapak went into the nasal pediatric cannula.

Manufacturer Narrative

(b)(4).The customer returned a nasal cannula and a 040 adaptor for evaluation.A visual exam was performed and no defects were observed.The 040 humidifier adaptor was connected to a 340 ml humidifier water bottle.The trigger on the water bottle was removed.The water bottle was attached to flowmeter asset a00630 and nasal cannula was attached to the water bottle trigger area.Flow meter was set to 2 lpm and let run for 2 minutes.No water was observed in the nasal cannula.The lpm was increased to 8 lpm and 10 lpm and let run for 2 minutes at each setting.No water was observed in the nasal cannula.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

Event Description

The customer alleges that water from the aquapak went into the nasal pediatric cannula.

• Brand Name: HUDSON ADAPTOR,040 HUM,INTL
• Type of Device: NEBULIZER 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5924513
• MDR Text Key: 53806888
• Report Number: 1417411-2016-00124
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 400040
• Device Lot Number: 26G15/26J15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2016
• 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