MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 1734

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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

The complaint is reported as: "oxygen tubing disconnected from nebulizer at 6-8 lpm." the issue was detected during use on a patient.No patient injury or consequence.The condition of the patient is listed as "fine".

Event Description

The complaint is reported as: "oxygen tubing disconnected from nebulizer at 6-8 lpm." the issue was detected during use on a patient.No patient injury or consequence.The condition of the patient is listed as "fine".

Manufacturer Narrative

Qn#(b)(4).The customer reported that the oxygen tubing disconnected from the nebulizer at 6-8 lpm.The customer returned components from catalog number 1734 up-draft ii opti-neb nebulizer w/reserv, batch 74b2002407.During the visual inspection, it was noted that a jet, jar, cap, tubing, mouthpiece, tee-connector and corrugated tubing were returned for analysis.During the visual inspection, no defects or anomalies were found with the returned components.A functional inspection was performed to determine if the oxygen tubing disconnects from the nebulizer at 6-8 lpm.The returned tubing was used to connect the nebulizer unit to the air flowmeter.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.During functional testing, mist was produced from the chamber of the nebulizer and the oxygen tubing did not disconnect from the nebulizer.No problems were found with the returned sample.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.The unit functioned as intended.

• Brand Name: HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10844434
• MDR Text Key: 216415940
• Report Number: 3004365956-2020-00232
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K760489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

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: 1734
• Device Lot Number: 74B2002407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 12/03/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1