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

Catalog Number 403128

Device Problem Disconnection (1171)

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer provided six photos for evaluation.A visual exam was performed and it was observed that there is an unstable connection of the adaptor to the flowmeter as it is described in customer complaint.It was also observed that the adaptor was taken apart from the nebulizer upper body.No other issues were found.The device history record of batch number 74l1601442 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.Based on the visual inspection of the provided pictures the complaint is confirmed.Although the condition observed on the pictures, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process.The actual sample is needed to perform a proper investigation and to determine a root cause.If the sample becomes available at a later date this complaint will be re-opened.

Event Description

The complaint is reported as: when the nebulizer adaptor was connected to the flowmeter, the upper connector came apart so the water bottle fell down.

• Brand Name: HUDSON ADAPTOR,028 NEB,INTL
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 8637751
• MDR Text Key: 146059345
• Report Number: 3004365956-2019-00125
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2019

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: 11/11/2021
• Device Catalogue Number: 403128
• Device Lot Number: 74L1601442
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2016
• 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