MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON IN-LINE NEB TEE WITH VALVEM; VALVED TEE ADAPTOR

Catalog Number 1743

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2015

Event Type  malfunction  

Event Description

The complaint is reported as: the in-line nebulizer tee with valve is reported as "popping off" (detaching) once flow pressure is achieved by the ventilator.No patient injury or harm reported.

Manufacturer Narrative

(b)(4).The device was not returned at the time of this report.

Manufacturer Narrative

(b)(4).The manufacturing and inspection records were reviewed and there were no issues related to the reported complaint found.The sample was not returned for evaluation; therefore, the complaint could not be confirmed.If the sample it returned, a follow-up report will be submitted with investigation results.

Event Description

The complaint is reported as: the in-line nebulizer tee with valve is reported as "popping off" (detaching) once flow pressure is achieved by the ventilator.No patient injury or harm reported.

• Brand Name: HUDSON IN-LINE NEB TEE WITH VALVEM
• Type of Device: VALVED TEE ADAPTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck drive; research triangle park NC 27709
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4866675
• MDR Text Key: 15307824
• Report Number: 1044475-2015-00213
• Device Sequence Number: 0
• Product Code: OGG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1743
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2015
• 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