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 07/16/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer alleges that the spring is malfunctioning and causing the nebulizer to pop off when connected to the compressed air supply.No patient injury/harm reported.

Manufacturer Narrative

(b)(4).The device was returned for evaluation.A visual exam was performed and no defects were found.The device was measured and was found to be within specification.It was also found that the spring worked normally when pressed.The product was manufactured in 2010 and the expiration date was 2013.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues were found with the returned sample.

Event Description

The customer alleges that the spring is malfunctioning and causing the nebulizer to pop off when connected to the compressed air supply.No patient injury/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: 4959876
• MDR Text Key: 23321955
• Report Number: 1044475-2015-00288
• Device Sequence Number: 1
• Product Code: GEF
• Combination Product (y/n): N
• Reporter Country Code: BD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1743
• Device Lot Number: 100315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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