MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-28J

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Customer complaint reads "the user found it difficult to connect the adaptor to the flowmeter; their screw threads were not easily fixed.Therefore, a new unit was used instead".Alleged issue reported as occurred during a patient use.

Manufacturer Narrative

(b)(4).One (1) unit of 031-28j "nebulizer adaptor 028, sterile, shelfpak" was received for analysis.During visual inspection the sample was not received in its original package.No other issues were found.The sample was tested on oxygen entrainment test and during the setup it was observed that the assembly of the nut adaptor component and the upper body component was unstable.Even with that condition, the sample was able to be tested on oxygen entrainment testing but the testing failed due such condition.After the testing finished, the nut adaptor was carefully disassembled from the upper body and it was visually inspected.During the visual inspection it was found wear on its internal tabs.The device history record of batch number 74j1701930 has been 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 complaint has been confirmed.Although the condition observed on the sample provided, 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 caused an unstable connection issue.

Event Description

Customer complaint reads "the user found it difficult to connect the adaptor to the flowmeter; their screw threads were not easlily fixed.Therefore, a new unit was used instead." alleged issue reported as occurred during a patient use.

• Brand Name: HUDSON NEBULIZER ADAPTOR 028,STERILE,SHELFPAK,
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8473200
• MDR Text Key: 140614212
• Report Number: 3004365956-2019-00094
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/27/2022
• Device Catalogue Number: 031-28J
• Device Lot Number: 74J1701930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOW METER.; FLOW METER.; FLOW METER.