MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-33J

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

(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: "the user found air seemed to be leaking from the connecting part assembly to the flowmeter before use on a patient.Therefore, a new unit was used instead." no patient involvement.

Event Description

The complaint is reported as: "the user found air seemed to be leaking from the connecting part assembly to the flowmeter before use on a patient.Therefore, a new unit was used instead." no patient involvement.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was found that the puncture pin was missing.No other issues were found.In order to perform a functional inspection, the missing component (puncture pin) had to be assembled to the sample.The sample was then tested on the oxygen entrainment test with no functional issues.As an additional test the sample was tested on the oxygen entrainment test using a bottle of sterile water connected to the nebulizer adaptor and no air leaks were detected.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10580896
• MDR Text Key: 208356459
• Report Number: 3004365956-2020-00192
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K153010
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 031-33J
• Device Lot Number: 74H1900578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.