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 Patient Involvement (2645)

Event Date 08/06/2019

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

The complaint was reported as: "the user found it difficult to connect the adaptor to the flowmeter: the connecting part assembly was too unstable to be fixed.Therefore, a new unit was used instead." there was no patient involvement.

Event Description

The complaint was reported as: "the user found it difficult to connect the adaptor to the flowmeter: the connecting part assembly was too unstable to be fixed.Therefore, a new unit was used instead." there was no patient involvement.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was damage on the supply tubing.No other issues were found.The sample was connected on oxygen entrainment test and during the setup it was observed that the assembly of the nut adaptor and the upper body was unstable, but due to detected damage in the supply tubing, functional testing could not be performed.Afterwards, the nut adaptor was carefully disassembled from the upper body and it was visually inspected.During the visual inspection it was observed there was wear on the internal tabs.Based on the investigation performed the reported complaint was confirmed.Although the condition was 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 component was most likely caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection, although this could not be confirmed.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8931004
• MDR Text Key: 155522919
• Report Number: 3004365956-2019-00217
• 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: 08/06/2019

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: 07/17/2023
• Device Catalogue Number: 031-33J
• Device Lot Number: 74G1801777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED; NONE REPORTED