MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/ELONG; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 1885

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

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

Event Date 10/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information obtained, for clarification, from the customer states the leak was an oxygen leak from the medicine cup which would not mist.A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device, or a picture of the alleged defect, was not provided at the time of this report.A device history record investigation shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper and thorough investigation to confirm the alleged defect and determine the root cause, it is necessary to evaluate the sample involved in this complaint.If the sample becomes available this investigation will be updated with the evaluation results.

Event Description

Customer complaint alleges "(b)(6) hospital complained the small volume nebulizers leakage and no mist came out." customer reports alleged defect detected during pre-testing prior to patient use.There was no report of patient harm or consequence.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was residue inside of the jet, jar, cap, tubing, and mask.The tubing was wrapped around the assembled nebulizer.The tubing was bent and kinked.Functional testing was performed and 5cc of water was added to the returned nebulizer unit and tubing was connected to an air flowmeter and the pressure was increased to 8 lpm.The testing was performed for 5 minutes and indicated that mist was produced and that the nebulizer did not leak.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.The device functioned as intended.

Event Description

Customer complaint alleges "(b)(6) complained the small volume nebulizers leakage and no mist came out." customer reports alleged defect detected during pre-testing prior to patient use.There was no report of patient harm or consequence.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/ELONG
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• 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: 6991575
• MDR Text Key: 91537086
• Report Number: 3004365956-2017-00385
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K930525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/02/2021
• Device Catalogue Number: 1885
• Device Lot Number: 74J1600281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2017
• 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