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 Known Impact Or Consequence To Patient (2692)

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided.However, a visual and functional inspection was performed to (b)(4) production samples of code ip-5036, batch 74j1700049 that were taken randomly from assembly line.Catalog number ip-5036 uses the same subassembly ph12153 than catalog number 031-33j related to this customer complaint.During the testing and visual inspection no issues or discrepancies were found than can lead to the condition reported by the customer.A device history record investigation shows that the device was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based on this investigation findings.It is necessary the physical sample in order to perform a proper investigation to confirm the alleged defect reported.If the device sample becomes available this report will be updated.Personnel of the assembly line were notified for awareness.

Event Description

Customer complaint alleges "it was report that the connection between the adaptor and oxygen flowmeter was unstable" alleged defect reported as detected prior to patient use.No report of patient harm or delay in treatment.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• 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: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 6893644
• MDR Text Key: 87857256
• Report Number: 3004365956-2017-00358
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/23/2021
• Device Catalogue Number: 031-33J
• Device Lot Number: 74H1602627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2016
• 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