MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,SHELFPAK

Catalog Number 031-28

Device Problems Leak/Splash (1354); Connection Problem (2900)

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

Event Date 11/05/2015

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 or a picture of the defect was not provided.The device history record (dhr) of batch number (b)(4) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.No corrective action can be established at this moment since the device sample or picture of it are not available for evaluation.Customer complaint cannot be confirmed due to the lack of sample.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 the device sample becomes available this compliant will be reopened.However, the personnel from the assembly line were notified in order maintain awareness of this type of issues.

Event Description

The customer alleges that the water leaked out due to a loose connection of the nebulizer adaptor.A new device was used without issue.

Manufacturer Narrative

(b)(4).One unit of subassembly ph12161-028 intl neb adaptor phantom holder was received for analysis.This subassembly is part of the finished good (b)(4) adaptor, 028 neb, intl.A visual exam was performed and it was observed that the sample was used, and there was a loose connection on the nebulizer assembly.In addition to the loose connection, adhesive residue was found on the tubing.No other issues were found.The tubing was measured and it was found that the internal diameter did not meet the current specification.Pull testing could not be performed due to the loose connection between the puncture pin and the tubing; however, a lift test was performed and the sample met current specifications.During the visual and dimensional inspection it was found there was a loose connection between the puncture pin and the tubing, therefore, customer complaint was confirmed.It was determined that the dimensional issue of the tubing was the cause of the problem reported by the customer.Personnel on the assembly line were notified on jan-14-2016.In addition, a non-conformance has been opened to address the issue.

Event Description

The customer alleges that the water leaked out due to a loose connection of the nebulizer adaptor.A new device was used without issue.

• Brand Name: HUDSON NEBULIZER ADAPTOR 028,SHELFPAK
• Type of Device: NEBULIZER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5233480
• MDR Text Key: 31713600
• Report Number: 3004365956-2015-00353
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 031-28
• Device Lot Number: 74C1503424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2016
• 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