MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 1883

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Complaint reported as: "drugs leak through long lines when operated with inhalation drugs before patient use." it was reported that the medication was leaking from the tube.No patient injury or harm reported.

Event Description

Complaint reported as: "drugs leak through long lines when operated with inhalation drugs before patient use." it was reported that the medication was leaking from the tube.No patient injury or harm reported.

Manufacturer Narrative

Qn# (b)(4).The customer returned one unit of catalog number 1883 micro mist nebulizer w/tee, tubing and mouthpiece, which consisted of a jet, jar, cap, tubing and corrugated tubing.During the visual inspection, no defects or anomalies were observed.A functional inspection was performed to determine if the nebulizer leaked.The tubing was used to connect the nebulizer unit to the air flowmeter and 6cc of water was added to the returned nebulizer unit and the tubing was connected to an air flowmeter.The pressure was increased to 8 lpm.During functional testing, the nebulizer unit did not leak.The device history record of batch number 74b1901736 was reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.The reported complaint that the nebulizer leaked during use was not confirmed during the functional inspection.During functional testing, the nebulizer unit did not leak.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9375053
• MDR Text Key: 190130984
• Report Number: 3004365956-2019-00344
• 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: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1883
• Device Lot Number: 74B1901736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INHALED MEDICATIONS; INHALED MEDICATIONS