MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HUMIDIFIER ADAPTOR 040; RESPIRATORY GAS HUMIDIFIER

Catalog Number 000-40

Device Problem Fitting Problem (2183)

Patient Problem No Code Available (3191)

Event Date 01/13/2016

Event Type  Injury  

Manufacturer Narrative

Complaint description reports that the patient "arrested." the type of arrest is not reported.The condition of the patient, both prior to and after the event described in this complaint, is unknown.It is unclear on the product complaint form.The investigation into this event is currently in progress.

Event Description

Customer complaint alleges "according to supervisor of pulmonary department, the new adaptor of aquapak 340ml does not fit easily in their oxygen flow meter.They have a hard time to connect the adaptor to their present oxygen flow meter.Two consultants a pulmonologist and a cardiologist complained because their patient arrested due to the delay in set up for oxygen.".

Manufacturer Narrative

(b)(4).The sample was not available for investigation.Based on the lot# reported (18g15), the lot numbers for component mp-0321 (snap-on flowmeter adaptor) were obtained.Records reviewed showed that there were no issues related to functional issues on the molded component involved in this complaint (batch # 1-2115741, 1-2015742, 4-2015742, 6-2015741, 6-2015742 & 7-2015741) during the manufacture of the material.The 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 on this complaint.Regarding other customer complaints for this same issue, a capa ((b)(4)) was opened to address this issue.According to the capa investigation thus 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.Several attempts were made to obtain the status of the patient.No information was received.If the sample is returned, or additional information is received, a follow-up report will be submitted.

Event Description

Customer complaint alleges "according to supervisor of pulmonary department, the new adaptor of aquapak 340ml does not fit easily in their oxygen flow meter.They have a hard time to connect the adaptor to their present oxygen flow meter.Two consultants a pulmonologist and a cardiologist complained because their patient arrested due to the delay in set up for oxygen.".

• Brand Name: HUDSON HUMIDIFIER ADAPTOR 040
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6178840
• MDR Text Key: 62520264
• Report Number: 1417411-2016-00136
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: RP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 000-40
• Device Lot Number: 18G15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2016
• 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
• Treatment: OXYGEN FLOW METER
• Patient Outcome(s): Other