MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE

Catalog Number 031-33J

Device Problems Restricted Flow rate (1248); Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2015

Event Type  malfunction  

Event Description

The customer alleges that the adaptor could not vapor during use.A new adaptor was used without any problem.Patient condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).No visual inspection can be performed since the device sample is not available for evaluation.No functional inspection can be performed since the device sample is not available for evaluation.The device history record of the product 031-33j with batch number 02a1400007 has been reviewed and no issues or discrepancies were found that could potentially relate to this complaint.Manufacturing (wi-con-001 rev.07) and quality inspection (tp-0041 rev.07) and quality inspection (tp-0041 rev.02) procedures and processes were reviewed and showing that proper controls are in place to guarantee that acceptable product is delivered to our customers.No conclusion can be established at this time based on the lack of device sample.It is necessary the physical sample in order to perform a properly investigation.If the product sample becomes available this complaint will be reopened.This complaint was notified to the personnel involved in the manufacturing process.Failure mode could not be duplicated since it is unknown the reason why the adaptor could not vapor during use, however functional test was performed to 30 subassembly (p/n: 12136) no issues or discrepancies were found.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033, STERILE, JAPANESE
• Type of Device: ADAPTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; ave. industrias no.5954; parque industrial finsa; nuevo laredo, tamaulipas 8827 5; MX 88275
• Manufacturer Contact: margie burton,rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4635736
• MDR Text Key: 5617903
• Report Number: 3004365956-2015-00101
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 031-33J
• Device Lot Number: 02A1400007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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