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

Model Number IPN049807

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A visual inspection of the product involved in the complaint was performed on a video received by the customer of product code 1885 (micro mist nebulizer w/elong).During the visual inspection on the received video, the tubing disconnection from nebulizer was observed.Although, tubing disconnected from nebulizer was observed on the provided video, the sample needs to be evaluated to confirm this issue as a manufacturing defect.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported "the nurse was preparing to atomize the patient, and when the product was assembled, it was found that the connecting port of the product connecting tube and the bottom of the medicine cup slipped naturally during installation, and it could not be connected and used normally".No patient involvement reported.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/ELONG
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 12280861
• MDR Text Key: 265171365
• Report Number: 3004365956-2021-00243
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 14026704645920
• UDI-Public: 14026704645920
• 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
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN049807
• Device Catalogue Number: 1885
• Device Lot Number: 74D2001138
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2020
• 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