MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICROMIST NEBULIZER; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 1880

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received by the manufacturer for evaluation at the time of this report.A device history record review could not be conducted since the lot number provided is not a valid lot number at teleflex (b)(4).Customer complaint cannot be confirmed based only on the information provided.To perform a proper and thorough investigation , and determine the source of defect reported , it is necessary to evaluate the sample involved.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "neb did not mist and sputtered treatment medication".No patient injury or consequence was reported.

Manufacturer Narrative

(b)(4).The customer returned one sealed representative kit along with an ifu attached to the outer sealed representative kit of catalog number 1880 micromist nebulizer for analysis.The kit contained a jet, jar and cap.The returned sealed representative kit was opened and visually inspected.No defects or anomalies were found.A functional inspection was performed and 5cc of water was added to the representative nebulizer unit.A lab inventory tubing was connected to an air flowmeter and the pressure was increased to 8 lpm.Functional testing indicated mist was produced from the chamber of the nebulizer and the nebulizer did not sputter.Therefore, based on the functional inspection, the customer complaint could not be confirmed.The reported complaint that the nebulizer did not mist could not be confirmed through functional inspection of the representative sample.Functional testing of the representative sample indicated a mist was produced from the chamber of the nebulizer and the nebulizer did not sputter.Because the actual sample was not returned, the root cause of this investigation is undetermined.

Event Description

Customer complaint alleges "neb did not mist and sputtered treatment medication".No patient injury or consequence was reported.

• Brand Name: HUDSON MICROMIST NEBULIZER
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8180672
• MDR Text Key: 130895540
• Report Number: 3004365956-2018-00374
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K930525
• 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: 12/10/2018

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: 1880
• Device Lot Number: 74H1802264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.