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

Catalog Number 031-33J

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

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

Customer complaint alleges the connection between the nut adaptor and the flow meter was unstable.A new unit was used for treatment.No patient injury reported.Patient condition reported as "fine".

Event Description

Customer complaint alleges the connection between the nut adaptor and the flow meter was unstable.A new unit was used for treatment.No patient injury reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4).One (1) unit of 031-33j "nebulizer adaptor 033, sterile, japanese" was received for analysis.Signs of use are observed since the sample was not received on its original package.Also, during visual inspection it was observed that the adaptor doesn't spin freely.No other issues were found.Oxygen entrainment testing was performed and during the setup it was observed that the assembly of the nut adaptor and the upper body was unstable.Even with that condition, the sample was able to be tested on oxygen entrainment testing but the testing failed due to the unstable condition.After the testing finished, the adaptor was carefully disassembled from the upper body and it was visually inspected.During the visual inspection wear was found on the internal tabs.Based on the investigation performed, the complaint is confirmed.Although the complaint is confirmed, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process.The wear on the internal tabs of the adaptor was most likely caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection issue.

• 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: 9350021
• MDR Text Key: 189880930
• Report Number: 3004365956-2019-00325
• 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: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/25/2023
• Device Catalogue Number: 031-33J
• Device Lot Number: 74K1801917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.