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

Catalog Number 1885

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record of batch number 74f1801134 that belong to catalog number 1885 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.The device has been received for evaluation, however the evaluation is still in progress at the time of this report.A follow up report will be submitted at the conclusion of the device investigation.

Event Description

Customer complaint states "head nurse found the cup leakage when the medicine was injected into the cup prior to use on patient.Replaced new one to complete the treatment.Patient is fine.".

Event Description

Customer complaint states "head nurse found the cup leakage when the medicine was injected into the cup prior to use on patient.Replaced new one to complete the treatment.Patient is fine.".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual inspection was performed and damage on the nebulizer jar was observed.No leakage i ssues could be confirmed as a functional inspection test could not be performed due to damage on the nebulizer jar.The received sample does not produce mist at all due to damage on the nebulizer jar, and there is not sufficient evidence to assure this issue was originated during the manufacturing process.The root cause for the condition reported could not be identified.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/ELONG
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8399503
• MDR Text Key: 138109299
• Report Number: 3004365956-2019-00062
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

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: Health Professional
• Device Expiration Date: 06/12/2023
• Device Catalogue Number: 1885
• Device Lot Number: 74F1801134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 03/21/2019
• Supplement Dates FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.