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

Catalog Number 403128

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 11/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The lot number provided for this complaint (18f091) does not correspond to the product reported by the customer.

Event Description

Customer reported the adaptor was unstable when connected to the flow meter and the water bottle fell down.No patient involvement reported.

Event Description

Customer reported the adaptor was unstable when connected to the flow meter and the water bottle fell down.No patient involvement reported.

Manufacturer Narrative

Qn#(b)(4).One (b)(4) unit of (b)(4) "adaptor,028 neb,intl" was received for analysis.A visual exam was performed and it was observed that the nut adaptor did not spin freely.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 to the condition.After the testing finished, the adaptor was carefully disassembled from the component upper body and it was visually inspected.During the visual inspection it was found wear on its internal tabs.Based on the additional inspection on the adaptor of the sample received, the complaint is 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 is most likely be caused by the end user during the connection of the adaptor into the flowmeter that causes an unstable connection issue.

• Brand Name: HUDSON ADAPTOR,028 NEB,INTL
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9416551
• MDR Text Key: 190015671
• Report Number: 3004365956-2019-00350
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

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 Catalogue Number: 403128
• Device Lot Number: 18F091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.