MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER W/PED MASK & TBG, SMALL VOLUM; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 41894

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint reads "the nebulizer tubing jumps off at oxygen point." alleged issue reported as detected during functional testing prior to a patient use.There was no report of patient harm or necessary intervention.

Manufacturer Narrative

(b)(4).The customer reported that "the nebulizer tubing jumps off at oxygen point." the customer returned one kit of catalog number 41894 nebulizer w/ped mask & tbg, small volume for analysis.During the visual inspection, it was observed that the tubing was bent at the bottom near the reduce hose nose.Visual inspection of the returned sample could not confirm the defect; therefore, a functional inspection was performed to determine if the tubing pops off the nebulizer during functional inspection.The returned tubing was used to connect the nebulizer unit to the air flowmeter.Per tp-0183 rev 14, functional testing indicated that mist was produced from the chamber of the nebulizer and that the tubing did not pop off after nebulizing.Therefore, based on the functional inspection, the customer complaint could not be confirmed.The device history record of batch number 74f1800398 that belong to catalog number 41894 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.The reported complaint that the tubing pops off at oxygen point was not confirmed during functional inspection.During the functional inspection, the tubing did not pop off at the oxygen point.The device history record of batch number 74f1800398 that belong to catalog number 41894 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No functional issues were found with the returned complaint sample.

Event Description

Customer complaint reads "the nebulizer tubing jumps off at oxygen point." alleged issue reported as deteceted during functional testing prior to a patient use.There was no report of patient harm or necessary intervention.

• Brand Name: HUDSON NEBULIZER W/PED MASK & TBG, SMALL VOLUM
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8640218
• MDR Text Key: 146062656
• Report Number: 3004365956-2019-00126
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

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: No Information
• Device Expiration Date: 06/12/2023
• Device Catalogue Number: 41894
• Device Lot Number: 74F1800398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.