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

Catalog Number 003-40

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/29/2015

Event Type  malfunction  

Manufacturer Narrative

(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 yet at our facility.The device history record was reviewed and showed no issues related to function on the molded component in this complaint.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.An attempt to duplicate the failure mode was made, but at the time there is no inventory of the involved product code (003-40; aquapak 340 sw,340 ml w/040 adaptor) available at the facility and it is not being manufactured at the time; however regarding other customer complaints from this same issue, a capa file #(b)(4) was opened to perform a further investigation this issue.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.If device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the screw cap connector was not able to connect to the oxygen wall outlet.No patient injury reported.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and there were no issues observed.Based on the visual exam, the reported complaint could not be confirmed.The returned sample showed no damage on the threads of the adaptor.Although the complaint was not confirmed, this is a known issue and all personnel from the molding area related to this process were notified.In addition, a capa was opened to address the issue.

Event Description

The customer alleges that the screw cap connector was not able to connect to the oxygen wall outlet.No patient injury reported.

• Brand Name: HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR
• Type of Device: HUMIDIFIER, RESPIRATORY GAS
• 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: 5225976
• MDR Text Key: 31488381
• Report Number: 1417411-2015-00168
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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,Followup
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 003-40
• Device Lot Number: 698147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/06/2015
• Initial Date FDA Received: 11/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2016
• 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