MAUDE Adverse Event Report: TELEFLEX MEDICAL MICRO MIST NEBULIZER W/ELONG; NEBULIZER (DIRECT PATIENT INTE

Model Number IPN049807

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record of batch number 74g1801100 that belong to catalog number 1885 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The device history shows that the product was assembled and inspected according to our specifications.The customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.If defective sample becomes available at a later date this complaint will be updated as applicable.

Event Description

Reported event: the doctor found the tube broken when using it on the patient.It was changed to a new one.There was no impact on the patient.

Manufacturer Narrative

Qn# (b)(4).Report 3004365956-2023-00004 is being retracted.The report was submitted by mistake.Teleflex no longer owns the registration.

Event Description

Reported event: the doctor found the tube broken when using it on the patient.It was changed to a new one.There was no impact on the patient.

• Brand Name: MICRO MIST NEBULIZER W/ELONG
• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16283306
• MDR Text Key: 308733757
• Report Number: 3004365956-2023-00004
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 14026704645920
• UDI-Public: 14026704645920
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K930525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2023
• Device Model Number: IPN049807
• Device Catalogue Number: 1885
• Device Lot Number: 74G1801100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED