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.One (1) picture and one video of " adaptor, 028 neb, intl" were received for analysis.During the visual inspection it can be observed that there is an unstable connection of the adaptor to the flowmeter as it's described in customer complaintand also is observed that the adaptor was taken apart of the nebulizer upper body.No other issues were found.An attempt to inspect current stock of material was made but at the time there is no inventory of the involved product code available at the facility nor is being manufactured at the time.No other issues were found.Based on the visual inspection of the provided video the complaint is confirmed.Although the condition observed on the video, there is not enough evidence to assure that this issue was originated during the manufacturing assembly or molding process.Based on previous statements it is not possible to establish a corrective action.If defective sample becomes available later this complaint will be re-opened.

Event Description

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

• Brand Name: HUDSON ADAPTOR,028 NEB,INTL
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 9416782
• MDR Text Key: 169352747
• Report Number: 3004365956-2019-00356
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K153010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• 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?: Yes
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.